－ 339 －－ 341 －－ 343 －National Agency for Drug and FoodControl
Republic of Indonesia
Tokyo, Japan
July 2016

1

VisionMission

Safe Food and Medicine to Improve Public
Health and National Competitiveness.

 Intensifying Risk-based Drug and Food Control
System to protect public health Encouraging Self Reliance of Bussiness Actors
in ensuring Drug and Food Safety andstrengthening partnership with stakeholders
 Enhancing NADFC institutional capacity.

－ 345 －

CHAIRMAN OF BADAN POM

Inspectorate

PERMANENT SECRETARY••••

National
Laboratory ofDrug & FoodControl

DEPUTY FOR THERAPEUTICPRODUCTS AND NARCOTICS,
PSYCHOTROPIC AND ADDICTIVE
SUBSTANCES CONTROLDEPUTY FOR TRADITIONALMEDICINES, COSMETIC ANDCOMPLEMENTARY PRODUCTCONTROL

Directorate for:• Drug and Biological Products Evaluation• Therapeutic Products Standardization• Therapeutic Product and Consumer Goods
Production Control• Therapeutic Product and Consumer Goods
Distribution Control• Narcotics, Psychotropic and Addictive
Substance Control

Directorate for:• Traditional Medicines, Food Supplemen
and Cosmetic Evaluation• Traditional Medicines, Cosmetic andComplementary Product Inspection andCertification• Traditional Medicines, Cosmetic andComplementary Product Standardization• Indonesia Indigenous Medicines

Bureau of Planning and Financing
Bureau of International Cooperation
Bureau of Legislation & Public Relation
Bureau of General Affairs

Centre of Drug
& FoodInvestigation

Centre ofDrug & Food
Research

Centre ofDrug & Food
Information

DEPUTY FOR FOOD SAFETY AND
HAZARDOUS SUBSTANCESCONTROL
Directorate for:• Food Safety Evaluation• Food Products Standardization• Food Products Inspection and Certification• Surveilance and Food Safety Extension• Product and Hazardous Substances
Control

32 Regional Offices

Organization of Directorate Of Drug And Biological ProductEvaluation
Directorate of Drug and Biological
Product Evaluation

Sub Directorate of
New Drug Evaluation

New Drug Evaluation
Section Path I & III

New Drug Evaluation Section
Path II

Sub Directorate of
Copy Drug and Biological
Product Evaluation
Copy Drug Evaluation
SectionDrug Reevaluation Section

Sub Directorate of
Evaluation on ProductTherapeutic for Special
PurposeClinical Trial ProductEvaluation Section

Therapeutic Productfor Special Access Scheme
SectionBiological ProductEvaluation Section

Administration andOperational Section
4－ 346 －

Drug Regulatory System
in Indonesia
 Pre Market Control
 Post Market Control

CORE OF REGULATORY FUNCTION
Pre-Market

Post-Market• Review and approval of
medicinal products for clinical
trials  Clinical Trial
Authorization (CTA); importpermit• Safety monitoring & risk-benefit
assessment of marketed products• GMP (Good Manufacturing
Practices) inspections of
medicinal products
manufacturers, including
biologicals• Quality surveillance of marketed
products• Benefit-risk assessment andapproval of medicinal products,
including biologicals  Market
Authorization• Investigation & enforcement ofregulation administered by NADFC• Risk communication & provision ofunbiased information to healthcare
professionals & consumers• GMP and GDP (Good Distribution
Practices) inspections• Prosecution of offenders－ 347 －

PRE MARKET CONTROLDRUG EVALUATION/REGISTRATIONThe Role of NADFC on Drug Registration••

Regulation of the Minister of HealthNo.1010/MENKES/PER/XI/2008 on Drug Registration
Decree of Head of NADFC No. HK.03.1.23.10.11.08481,
2011 on Criteria and Procedure of Drug Registration

Therapeutic product to be marketed inIndonesia shall be registered throughregistration process in NADFC prior toMarketing Authorization－ 348 －

ASEAN Guideline For Evaluation
 ASEAN Guideline on Submission of Manufacturing
Process on Validation Data for Drug RegistrationASEAN Guidelines for Validation of Analytical
Procedures
ASEAN Guideline on Stability Study of Drug ProductASEAN Guidelines for the Conduct of Bioavailability
and Bioequivalence Studies
The ASEAN Common Technical Dossier (ACTD) for theRegistration of Pharmaceuticals for Human Use.
ICH Guidelines
WHO TRS Reports
9Good Manufacturing PracticeInspection

GMP

CERTIFICATION

 Manufacturer should confirm with GMP requirements
 GMP Certificate will be given if the requirements is
confirmed
 GMP Certificate is issued for each dosage form

－ 349 －

WHO SHOULD
APPLY?

Pharmaceutical Industries
Located in Indonesia MAH
How to apply
registration forMA?

Pre-registration* Determination of the registration category andevaluation path/timeline* Consultation on completeness of registration
dossier/document* Registration Fee

Registration* Submit registration dossier according to theregistration category ,completed with bankreceipt of registration fee
11

POST MARKET CONTROLINSPECTION－ 350 －

INSPECTION

PharmaceuticalIndustries

GMP Inspector

Wholesalers

Pharmacies, Drug Stores,
Healthcare Facilities

GDP Inspector

Regulatory Actions

All facilities comply with regulation & Standard Ensure S,E & Q of Drug

INSPECTION

Legislation• National Law of Health No 36, 2009
• Government Regulation No 72 regarding Safeguarding ofPharmaceutical Product and Medical Devices• Ministry of Health Decree No 1799, 2010 regarding
Pharmaceutical Industry• Ministry of Health Decree No 1148, 20101 regarding
Wholesaler• Head of NADFC Regulation regarding Implementation of
GMP & GDP.

Standards• Indonesia GMP Code 2012 Edition• Indonesia GDP Code 2012 Edition• Operational Guidance for Industries• GMP Code for API Manufacturing Year 2009

－ 351 －

－ 352 －－ 353 －－ 354 －－ 355 －－ 356 －－ 357 －－ 359 －－ 360 －－ 361 －－ 362 －－ 363 －1监管体系和药师作用培训班开班汇报

Course of Roles of Regulatory System and Pharmacists on Ensuring
Proper Access to Quality Assured Medicines
Inception Report Presentation

王雪涛 中国China Xue tao Wang2016.07 Tokyo

2

汇报提纲
Outline of the presentation

01

情况介绍
Introduction of the work

02
03

良好实践
Good Practice经验总结
Difficulties/Lessons learned from past experience04－ 364 －

关注事项Interests

情况介绍Introduction

3

王 雪 涛
Wang xuetao
副巡视员

Deputy Inspector
药物政策与基本药物制度司
Department of Drug Policy & Essential Medicine
国家卫生和计划生育委员会
National Health and Family Planning Commission of P.R.C

职责： Roles and responsibilities负责基层药学人员基本药物合理使用培训
responsible for basic medicine personnel essential medicine rational use ，making training plan
参与药物采购供应政策制定
Participant in drug procurement supply policy-making

良好实践
Good Practice培训项目例子4

Training project example设立基层医务人员培训项目，组织编写基本药物临床用药指南和处方集
In 2011, Set up grassroots medical staff training project, Organizes compiling formulary and clinicalpractice guideline of essential medicine解决基层医务人员没有规范培训教材和培训项目
To solve no grassroots medical staff training project and standardized training materials

通过以上两个措施, 提高处方质量，促进合理用药，确保用药安全Through the above two measures, improve prescription quality, promote rational drug use ，ensure drug safety继续加强基本药物临床用药指南和处方集培训工作
At present, Continue to do formulary and clinical practice guideline of essential medicine training work

－ 365 －

Formulary and Clinical Practice Guidelines(Chemical Drugs and Traditional Chinese Medicine)

5

2009

2012

经验总结
Difficulties & Lessons

当前和重复出现问题

Current and Re-emerging problems 人员培训经费和制作教学光盘经费不足
Insufficient funds for personnel training funds and teaching CD manufacturing。

 培训模式单一，课堂教学为主。许多偏远地区没通网络,路远，经费不足，无法参加课堂和网上学习Training method is single，classroom teaching should be the priority. Many remote areas, no internet,
no fund ,road is far, neither take part in the classroom learning , nor can online learning 缺乏培训评估标准，难以了解掌握培训真实效果
Lacking of training evaluation criteria , it is difficult to grasp training actual effect－ 366 －

6

7

关注事项
Interests
 日本在药师培训方面的经验、模式、方法和经费来源
Experience, mode, method and funding source in training pharmacists in Japan 日本《药师法》的主要内容和立法经验
Main content and legislation experience of Pharmacist's Law in Japan 日本药品采购方法、报销方式
Drug procurement supply approach and drug reimbursement in Japan－ 367 －

－ 369 －－ 371 －－ 372 －－ 373 －－ 374 －－ 375 －－ 376 －－ 377 －－ 378 －－ 379 －－ 380 －•••－ 381 －

•
•
•
•
•
•

－ 382 －

••

－ 383 －

•
•
•
•

•
•

•

•
•

－ 384 －

••••

Department of food and drug administration – organization chart
Director General

Deputy director general (head quarter)

Director foodDirector drug

Deputy director general (State and region )Director medical device
and cosmetic

Director admin

Director lab
Branched Office
FDA (Ygn)

Branched Office
FDA (Ygn)

12 States/Regional
FDA

Co-State Eastern &northern Shan State

District FDA

Border Trade Zone FDA－ 385 －

Food and drug supervisory committee
Myanmar food and drug board of authority

Food advisory committee

Central food and drug supervisory committee

Drug advisory committeeState and region food and drug supervisory committee

District food and drug supervisory committee

Township food and drug supervisory committee－ 386 －

1

No. of Pharmacist

M Pharm – about 80
B Pharm – about
3000

2

No. of GMP Inspectors

10-20

3

No. of Pharmaceutical Manufacturers(8)

Manufacturing Sites

Yangon, Pyin Oo
Lwin,Kyaut Sae,
Sagaing

4

No. of Traditional Medicine

About 100

Manufacturers Manufacturing Sites
5

No. of Pharmaceutical Importer

208

6

No. of Pharmaceutical Wholesalers>700

Regulatory Services－ 387 －

Regulatory Services

Regulatory Services－ 388 －

Regulatory Services•••

Regulatory Services••－ 389 －

Regulatory Services••

Regulatory Services••－ 390 －

Regulatory Services••

Regulatory Services•－ 391 －

Regulatory Services•

Regulatory Services••••－ 392 －

Regulatory Services••

Regulatory Services•－ 393 －

Good practices
counters measure against the fake drugs

Good practices
GSP, GPP Inspection )－ 394 －

Good practices
Notify the public

Good practices
Mini-laboratory services－ 395 －

Good practices
Management of expired products

Good practices
Management of expired products－ 396 －

Good practices
Trainings

Good practices
Public awareness－ 397 －

Good practices
Public awareness

Challenges

•
•

•
•
•

－ 398 －

－ 399 －－ 401 －－ 402 －－ 403 －－ 404 －－ 405 －－ 406 －－ 407 －－ 408 －－ 409 －－ 410 －－ 411 －－ 412 －－ 413 －－ 415 －－ 416 －－ 417 －－ 418 －－ 419 －－ 420 －－ 421 －－ 422 －－ 423 －－ 424 －－ 425 －－ 426 －－ 427 －－ 428 －－ 429 －"Roles of Regulatory Systems andPharmacists on
Ensuring Proper Access to Quality Assured
Medicines”
COUNTRY PRESENTATION: PAPUA NEW GUINEAKILEPA WILLY FEBIMEDICAL SUPPLIES DISTRIBUTION UNIT
NATIONAL DEPARTMENT OF HEALTH

Introduction
 Pop: 7.5 million

 Language: 700 plus,

Official Language English and Pidgin－ 431 －

Organization

 National Department of Health National Health Policy & Corporate Services
 Corporative Services Division
 Medical Supplies Procurement & Distribution Branch (MSPDB)–was created recently in 2011 after recommendation by AusAID in 2008
We are working to develop, improve and align drug regulatory systems
 Job tenure – Pharmacist by Profession ‐Technical Advisor –Medical Supplies

Distribution & Area Medical Stores ‐Almost 4 years of service now, joined in late2013.

 Regulatory Services engaged in –Quality Control of pharmaceuticals duringstorage anddistribution, but support across other Regulatory Areas where required as we build our systems.

Organizational Structure – Ministry of
HealthOffice of the
Minister of HealthNational HealthPlan &
Corporate
Services
Strategic
PolicyHealthServiceStandards

Office of theSecretary for
HealthMedicalStandards

Corporate
Services
MedicalSupplies

Procurement

Distribution

Public HealthPharmaceutical
Services Standards
PharmaceuticalCare－ 432 －

Compliance &Inspection

Product
Registration

Quality
ControlGood Practise
Experiences/Examples


All Area Medical stores are poorly manage due to no Good Storage Practise in placed

No Good Distribution Practices for the distribution of medical supplies



Biggest challenges in sourcing medicines from WHO prequalified manufactures

Achievements

Creation and Designation of Medical Supplies Procurement & Distribution Branch andPharmaceutical Regulatory Branch in 2010

Development of National Procurement Plan and Distribution Plan(5 years plan-2014-2019)

Revision of the Medicines Policy and passed by Gov;t2014

Solutions for past problems
Good Storage Practices (GSP), Good Distribution Practices (GDP) and Good Pharmacy Practice (GPP) ‐WHO StandardSourcing of medicines and vaccines from WHO prequalified manufacturers



Quality Testing in WHO accredited labsDevelopment of Standard Operation Procedures for the Branch,2016

Good Practise cont..
Ongoing projects to deal with current problems
 Improve drug registration process and guidelines for commenceme

nt of registration

 Creation of position for Quality Assurance officers at the Area

Medical Stores

 Revision of Act and Regulations in partnership with PSSB No GMP clearance for overseas manufacturers
 No Regulation of price for medicines .

 Very little post market surveillance－ 433 －

Difficulties/Lessons learn from thepast
Maintaining the quality of drugs along the supply chain, especially from the storage at AMSs and Distribution to the facilities
What we have done
 Adopt good practise guidelines (WHO) Ran Training for staff
 Invite NGOs to help

Still have issue with storage and Distribution

Way forward Learn and adopt good practices from other countries

 Ensure strict adhere of Good Practice Guidelines at all levels
 Provide more training on supply chain which more emphasis can begiven to quality assurance.

－ 434 －

Area of Interest Market Approval (generics)

 GMP
 Countermeasure against counterfeits medicines.

－ 435 －

－ 437 －Role of Regulatory System andPharmacist on Ensuring Proper Accessto Quality Medicines
Duration course 6th July to 1oth August 2016
Pharmacist: Hayder Abdul Ameer Kadhim
Ministry of Health/Technical affairs
directorate/Pharmacy department

IRAQ Demographic Data
Total population: 36,933,714 million in 2015 with growth rate of 2.5 %.
40,2% of the population is under 15 years of age and 5,01% is over 60
years.
Urban population is about 69.9% of the total population.
Life expectancy at birth estimated at 72.56 (71.2 for males and 73.98 forfemales) .
Infant mortality rate among under 5 years has fallen gradually to be
25.2/per 1,000 live births.
Children dying before the age of 1 year dropped to be 19.7 for every
1,000 live births.
•* This information from annual statistical report 2015 /Republic of Iraq/ Ministryof Health－ 439 －

IRAQ

IRAQ
Mesopotamia, from the Ancient Greek: Μεσοποταμία "[land]
between rivers"; Arabic: ‫" بالد الرافدين‬land of rivers") is a namefor the area of the Tigris–Euphrates river system, roughly
corresponding to modern-day Iraq,*Is a country in Western Asia . The country borders Turkey tothe north, Iran to the east, Kuwait to the southeast, Saudi
Arabia to the south, Jordan to the southwest, and Syria to thewest. The southern part of Iraq is within the Arabian
Peninsula. The capital, Baghdad, is in the centre of the country
and its largest city. The largest ethnic groups in Iraq are Arabs
and Kurds. Other ethnic groups include Assyrians, Turkmen,
Yazidis, Armenians－ 440 －

Economy of Iraq
*Oil

Iraq's economy is dominated by the oil sector, which has provided about
95% of foreign exchange earnings in modern times*Agriculture

Given the richest land of Iraq with water in the past, the agriculture
sector is an important part of the Iraqi economy to soon. The mostimportant products are seeds, grains, dates, vegetables and fruit.
Agricultural areas concentrated around the Tigris and Euphrates rivers
and their branches. But the drought that hit central and southern Iraq
because of climate change led to agriculture has fallen sharply in Iraq at
the moment.

*industry

Diverse industries in Iraq and the Iraqi industry characterized byquality despite old factories, machinery and circumstances experienced
by Iraq. Among these industries, construction materials, petrochemicals,
tobacco and leather industry.

Top ten diseases causes of death in Iraq
Diseases1

Cerebravascular disease2

Neoplasm's

3

Ischemic heart disease

4

Heart failure

5

Renal failure

6

Hypertensive diseases

7

Respiratory Distress Syndrome

8

operations of war

9unknown causes of mortality

10

Diabetes mellitus－ 441 －

Health Services
Number of human resources works in Ministry ofhealth and rate per 10000 of population
Human resources
Physicians

26975

Pharmacists

8001

Nursing staffs

58687

Health assistants

653

Health Center and Hospital statistics
Infrastructure
Hospitals

253

Total number of governmental
hospitals’ beds

44554

Total number of Primary healthcare center.

2680
13000

Licensed pharmacies－ 442 －

Medicines Regulation
There is no law or act that provides power andresponsibilities to medicines regulatory
authority(MRA) there are ministerial orders, law here
and there, The Directorate of Technical Affairs inministry of health in addition to the state owned
public pharmaceutical procurement and distribution
company(KIMADIA) and the Syndicate of pharmacy
play the role of a MRA ,the MRA is apart of MOH andhave number of functions and has its own website, forwhich the URL www.techmoh.net

Structure of the Pharmaceutical Sector
Syndicateofpharmacists
Licensing &inspection ofprivatepharmaceuti
calinstitutions

Ministry of
HealthKIMADIA
Dept of
Medicines
importation
Dept ofequipment
importation
Medicalappliances
Dept

General Inspector
OfficeDirectorate oftechnical

affairs

Committee
of medicines
selection
Committee of
herbalmedicines andfood
supplement
selection

Pharmacy
department

Registration
dept
Need
estimation
dept

Dept offinance

Lab of Quality
control

Drug
Information
BureauHerbalmedicine dept

KIMADIA= State Company for Procurement and Distribution of Medicines and Medical Appliances－ 443 －

Functions of the national
medicines regulatory authority
Function
Marketing authorization / registration
Inspection
Import control
LicensingMarket control
Quality control
Medicines adverting and promotion
Clinical trials control
Pharmacovigilance

1.Marketing authorization /registration
In Iraq, legal provisions requires marketing •authorization (registration) for all pharmaceuticalproducts on the market, there are over 7000
pharmaceutical products registered in Iraq. There
are legal provisions requiring the MRA to makethe list of registered pharmaceutical products
publically available and update it regularly. Thisupdated list can be accessed throughwww.techmoh.net－ 444 －

2.Regulatory Inspection
In Iraq ,legal provisions exist allowing for •appointment of government pharmaceuticalinspectors(law of practicing pharmacy 1970).Legal
provisions exist permitting inspectors to inspectpremises where pharmaceutical activities are
performed, such inspections are required by law
and are a pre-requisite for the licensing of public
and private facilities. Inspection are carried out ona number of entities for good manufacturing
practice such as(local manufacture, private
distributers wholesalers, retail stores, pharmacies,public pharmacies and dispensing points if healthfacilities).

3.Import Control
Legal provisions exist requiring authorization •to import medicines. Law exist that allow thesampling of imported products for testing .
Legal provisions exist requiring importationof medicines through authorized ports ofentry. Regulations or law exist to allow for
inspection of imported pharmaceuticalproducts at authorized ports of entry suchas(Official Regulation no.60,MOH(1998),lawof public health(1981),official regulation no.2
(2001),ministerial instructions(2008).
－ 445 －

4. Licensing
In Iraq ,legal provisions exist requiring •manufactures to be licensed(MOH,2007).Legal
provisions exist requiring manufactures(bothdomestic and international)to comply with good
manufacture practices(GMP).Legal provisions exist
requiring importers/ wholesalers and distributors
to be licensed, pharmacist to be registered, private
and public pharmacies to be licensed (law ofpracticing pharmacy 1970) .National Good
Pharmacy Practice Guidelines are published bygovernment(Ministerial instructions and Booklet
Practice(2010)) for Good Pharmacy

5.Market Control and Quality Control
In Iraq ,legal provisions exist for controlling the •pharmaceutical market ( law of practicing pharmacy
1970 , continuous ministerial instruction(2011) . A
laboratory exist in Iraq for quality control testing.
Medicines testing reasons
For quality monitoring in the public sector *For quality monitoring in the private sector **When there are complaints or problem reports
For product registration
For public program products prior to acceptance and/or
distribution* Routine sampling in pharmacy stores and health facilities** Routine sampling in retail outlets－ 446 －

The National Center for Drug Control and •Research (NCDCR) ); a quality control entity
belonging to the Technical Affairs Directorate- Ministry of Health. The Center conforms toand implements high quality pharmacopoeias
standards such as The International
Pharmacopeia, BP and USP . The NCDCR’s
growth and expansion in last years has
meant carrying out record numbers of tests
efficiently (more than 1,500 tests performed
per month i.e. doubling capacity from 2007).

Towards the end of 2014, the NCDCR
orchestrated a large scale drug control
campaign which resulted in testing large
quantities of contraband pharmaceuticals
available on Iraqi market shelves.
Approximately 17% of which did not meet the required
efficacy and safety standards. The importers werefined and the items were seized & destroyed before
reaching and harming Iraqi patients.
However, it is important to note that the majority oflegally imported medicines adhere to and pass the
NCDCR’s stringent quality control procedures.

－ 447 －

－ 448 －6.Medicines Advertising and Promotion
In Iraq ,legal provisions exist to control the •promotion and/or advertising of prescription
medicines. The ministry of health is responsible forregulating promotion and/or advertising of
medicines. Legal provisions prohibit directadvertising of prescription medicines to the public.

7.Clinical Trials
In Iraq ,legal provisions exist requiring •authorization for conducting clinical trials by
MRA. There are no additional laws requiring
the agreement by an ethics committee or
institutional review board of the clinical trials
to be performed.

－ 449 －

8.Controlled Medicines
Iraq is a signatory to number of international •conventions. Laws exist for the control of narcotic
and psychotropic substances, and precursors(Lawno.68 ,1965).
International Conventions to which Iraq is a signatory
Single Convention on Narcotic Drug,
1961
1972 Protocol amending the Single Convention on Narcotic Drug,
1961
Convention on psychotropic substances
1971

United Nations Convention against the illicit traffic in Narcotic drug
and psychotropic
substances,1988

9.Pharmacovigilance
A national Pharmacovigilance center linked to the •pharmacy department exists. An official standardized
form for reporting adverse drug reactions(ADR) in
Iraq. Information pertaining to ADRs is stored in anational ADR database. These reports are send to the
WHO collaborating center in Uppsala. There isnational ADR or pharrmacovigilance committee able toprovide technical assistance or causality assessment,risk assessment, risk management and case
The Pharmacovigilance center has its investigation .
own websites:(iqphvc@yahoo.com ,iraqiphcv@moh.gov.iq)－ 450 －

－ 451 －－ 453 －－ 454 －－ 455 －－ 456 －JICA inception report
Roles of Regulatory Systems and Pharmacists on
ensuring
proper access to quality assured medicines

Silverani Padayachee
National Department of HealthSouth Africa
O303030 October 201530
27 June 2016

Discussion points
1.
2.
3.
4.
5.
6.

7.

Organisational Chart
Legislation on Pharmaceutical administration
Regulatory Services
Drug Pricing
Statistical Data
Education and License of pharmacists in yourcountry
Side Effect report2－ 457 －

Organogram from National Level
From Director General to Programme Level

Organogram from Programme to Subprogramme level

Health Regulation and ComplianceFood Control,
Pharmaceutical Tradeand product regulation

Public Entities
Management－ 458 －

Compensation
Commissioner for
Occupational diseases
and Occupational HealthSub- programme: Food Control Pharmaceuticaltrade and Product regulation (FCPT&PR)

5

Sub- programme: Food Control Pharmaceuticaltrade and Product regulation (FCPT&PR)
Registrar of Medicines and Cluster Manager
Assistant
Directors
Directorate:
Inspectorate & Law
Enforcement

Executive
Assistants

Directorate:
Medicines
Evaluation &Research

Directorate: Clinical
Evaluation & Trials

Directorate: Operations& Administration

Deputy Director:
Inspectorate

Deputy Director:
Pre-registration

DeputyDirector: Preregistration

Deputy Director:
Operations andAdministration

Deputy Director:
Licensing

Deputy Director:
Post-registration

DeputyDirector: Postregistration

Registry

Deputy Director:
Veterinary

DeputyDirector: Clinical
Trials

Deputy Director:
Complementary
Medicines

DeputyDirector:
Section 21

Deputy Director:
Biological
Medicines

Deputy Director:
Pharmacovigilance

Deputy Director:
Law Enforcement－ 459 －

Finance
Logistics
Council
EDMS & eCTD

Legislation on Pharmaceutical administration• LEGISLATIVE AND OTHER MANDATES• The legislative mandate of the Department of Healthis derived from the Constitution, the National Health
Act, 61 of 2003, and several pieces of legislation
passed by Parliament.

7

Constitutional Mandates
•
•

•
•

•

In terms of the Constitutional provisions, the Department is guided by thefollowing sections and schedules, among others:
The Constitution of the Republic of South Africa, 1996, places obligations
on the state to progressively realise socio-economic rights, including
access to health care.
Schedule 4 of the Constitution reflects health services as a concurrent
national and provincial legislative competence
Section 9 of the Constitution states that everyone has the right toequality, including access to health care services. This means that
individuals should not be unfairly excluded in the provision of health care.
Section 27 of the Constitution states as follows: with regards to Healthcare, food, water, and social security:8－ 460 －

National Health Act, 61 of 2003
Provides a framework for a structured uniform health system within the Republic,
taking into account the obligations imposed by the Constitution and other laws on
the national, provincial and local governments with regard to health services
The objects of the National Health Act (NHA) are to:
•
•

•

•

•

unite the various elements of the national health system in a common goal to actively
promote and improve the national health system in South Africa;
provide for a system of co-operative governance and management of health services, within
national guidelines, norms and standards, in which each province, municipality and healthdistrict must address questions of health policy and delivery of quality health care services;establish a health system based on decentralised management, principles of equity,
efficiency, sound governance, internationally recognised standards of research and a spirit ofenquiry and advocacy which encourage participation;
promote a spirit of co-operation and shared responsibility among public and private healthprofessionals and providers and other relevant sectors within the context of national,
provincial and district health plans; andcreate the foundations of the health care system, and must be understood alongside otherlaws and policies which relate to health.

9Legislation falling under the Minister of Health’s
portfolio•

There are several legislations within the minister of healths portfolio, however only
those relevant to the regulation of medicines, pharmacy and related activities
have been listed below and are relevant both nationally and locally••

Medicines and Related Substances Act, 101 of 1965
Provides for the registration of medicines and other medicinal products to ensure theirsafety, quality and efficacy, and also provides for transparency in the pricing of medicines.
Foodstuffs, Cosmetics and Disinfectants Act, 54 of 1972 (as amended)
Provides for the regulation of foodstuffs, cosmetics and disinfectants, in particular quality
standards that must be complied with by manufacturers, as well as the importation andexportation of these items.
Pharmacy Act, 53 of 1974 (as amended)
Provides for the regulation of the pharmacy profession, including community service bypharmacists
National Health Laboratory Service Act, 37 of 2000
Provides for a statutory body that offers laboratory services to the public health sector.
Nursing Act, of 2005
Provides for the regulation of the nursing profession.

•
•

•
•
•
•
•
•

10
－ 461 －

PIC/S• SA MCC joined Pharmaceutical Inspectorate
Co-operation scheme on 1 July 2007 and isstrongly committed to the collaboration.

11

Regulatory services
Drug Import/Export• Systems
 Governance Issues
 Documents for importation
 Processes to be followed Roles of different stakeholders
 SARS Port Health MCC/NDoH
 Substandard Medicines
 Counterfeit Medicines
 Action to be taken
12－ 462 －

Regulatory Import and Export• Regulations-Imports and Exports controlled by
 Section 27 of the Constitution (Act 108 of 1998)- Every citizen of the Republic of South Africa has the right to access to healthcare facilities


Medicines and Related Substances Act, 1965 (Act 101 of 1965)− Makes provision for the control and access to medicines− Provides for medicines registration.
− Provides for the registration of facilities whereby medicines can be manufactured andstored− Provides for procedures to be adopted when selling medicines− Provides for dedicated port of entries for medicines− Provides for the appointment of Inspectors

 Promotion of Administration Justice Act, 2000 (Act 2 of 2000)
 Promotion of Access to Information Act, 2000 (Act•

Administered by- Medicines Control Council
13

Regulatory services
Pharmaceutical Manufacturing• Systems- Inspection programme drafted based on new sites; sites
requiring renewal; complaints received. SOP’s govern the processes
followed• Regulations• Administered by MCC using the following references• SA cGMP Guidelines can be accessed on www.mccza.com• PIC/s Guidelines can be accessed fromhttp://www.picscheme.org/publication.php?id• WHO Guidelines can be accessed fromhttp://www.who.int/publications/guidelines/en/

14－ 463 －

Regulatory services
Marketing authorisation/ Registration Process• Systems
Administrative Requirements• Receiving and screening of amendments• Human, biological, veterinary,Technical Requirements• Clinical safety and efficacy, Quality• Good Manufacturing Practices (GMP)• Good Clinical Practices (GCP)• Names, Scheduling

15

Registration Process• Admin– Reception & admin screening of application– Allocation of application number– Notification of number of copies required–• Receipt of additional copies for evaluation• Allocation of applications to Evaluators• Evaluation & draft of evaluation report• Peer review of report - Expert Committees－ 464 －

Registration Process cont• Regulations: 14; 15; 15 (A); 22
Medicines and Related Substances Act, 1965 (Act101/1965) [amended 16 times]• Administered by: Medicines control Council
Guidelines for safety, efficacy and quality arebased on WHO, EMA, FDA, TGA andrecognized pharmacopoeia
E.g;Good Quality practice17

Clinical data
NCEs
PA/PE

Section 1 (1)Interchangeable
multisource medicine:
Pharmaceuticalequivalents that are
therapeuticallyequivalent
Section 22F:
Generic substitution

MUST

Pharmaceuticalalternatives
that aretherapeuticallyequivalent

MAY substitute－ 465 －

Registration Process
Complies

Screening

Yes

Final application

No
Applicantresponse

Dispatch toevaluators

Reports to
Committees

No
Not accept

Complies

Yes

Back to relevant Committee

Product
to MCC

RejectAcceptRegister

19

Regulatory services* not regulated by MCC
Drug Distribution including drug selection, procurement and sale••••

Systems- Medicines Access Framework
The WHO Medicine Access Framework defines access as a function of four
elements.
Today’s focus is on achieving a reliable supply chain
However, reforms are taking place across each of these areas.

20－ 466 －

Medicines Access Framework

21

Regulatory services* not regulated by MCC
Drug Distribution including drug selection, procurement and sale
• Systems•

Regulations: Global & Local Imperatives

•
•
•
•
•
•
•
•

•Universal Declaration of Human Rights (1948 ), Article 25•The preamble to the Constitution of the WHO (1948)•The International Covenant of Economic, Social and Cultural Rights (ICESCR) Article 2•United Nations adopted 17 Sustainable Development Goals (SDGs) 25 September 2015
(Goal 3.8 of the SDGs)•South African Constitution and Bill of Rights , Section 27•National Health Act•National Development plan
•National Health Insurance White Paper•

Administered by- NDoH Sector wide procurement Unit, separate from the MCC

22－ 467 －

Medicine Safety (Post Marketing)
•
•

•
•
•

•

•
•

Systems - The following systems are used to manage ADRs
Adverse Drug Reaction Reporting Form (yellow form) used by Healthcare
Professionals and consumers - Received via fax and post
CIOMS forms from the applicants - Received via fax and post
Use of the Vigiflow system for capturing of ADR reports and committing them into
the Uppsala Monitoring Centre's Vigibase.
All these forms are initially screened by technical staff (pharmacists), thencaptured by the administration clerks into the Vigiflow system and verified bypharmacist before committing them onto the UMC's Vigibase. On a weekly basis,
causality is assessed for all serious cases before committing them.
In the process of piloting the electronic submission of ADR reports in the E2Bformat directly into the Vigiflow system by the applicants.
Good Pharmacovigilance Practice
We have Pharmacovigilance inspections which are currently reactive and working
towards being proactive. These inspections are done by qualified pharmacists who
are GMP trained.
23

Regulatory services
Medicine Safety (Post Marketing)•

Regulations - Adverse Drug Reaction reporting is according to Regulation
37 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as

amended.
••The applicant or holder of a certificate of registration or any authorizedprescriber in respect of a medicine or Scheduled substance shall informthe Authority, in the manner and within the time frame as determined by
the Authority, of suspected adverse drug reactions reported to him, her or
it occurring as a result of the use of such a medicine or scheduled
substance.
Administered by- Medicines control Council

24－ 468 －

Biologicals

Clinical Trials

NADEM
C
National
PV centre

Pharmacovigilance(PV)

Veterinary

Referrals toand from Council andCommittees including
during thepost-registration period

COUNCIL

Other
directorart
es in DOH
P&A

Scheduling

Clinical

Regulatory services
Relief system for adverse drug reactions• Systems- No relief systems in place from
Regulatory agency

26－ 469 －

Drug Pricing- Managed by NDoH Sector Wide
Procurement

Basis is National Drug Policy in 1996-“todevelop a pricing plan for drugs used in South
Africa in the public and private sectors”.
• multi-faceted series of interventions to
reduce medicines prices and also improveprescribing and dispensing practices.
• a policy of mandatory offer of genericsubstitution

27

Drug price control /drug price mechanism
A Pricing Committee with clearly defined functions to monitor and regulate
drug prices will be established within the Ministry of Health• • A pricing committee, to “monitor and regulate drug prices”• • Total transparency in the pricing structure (at all points of the
distribution chain)• A non-discriminatory pricing system within the private sector• • Replacing the wholesale and retail mark-up system with one based on a
fixed professional fee• • A database to monitor costs compared with other developing anddeveloped countries• • Regulation of price increases• • Provision, in certain circumstances, of public sector stock to the private
sector (e.g. supplying lower cost drugs bought by the State to private
sector clinics in order to address a priority disease)28－ 470 －

Drug price control /drug price mechanism cont…
• • Promotion of generics (multi-source pharmaceuticalproducts, generally cheaper than the originator’s branded
products), including generic substitution, while maintaining anegative list (a list of drugs that could not be substituted by
the pharmacist at the patient’s request, but where theprescribed brand would have to be supplied)• • Measures to improve rational drug use, including
establishing Pharmacy and Therapeutics Committees (PTCs) inall hospitals• • Control of pharmaceutical marketing practices.

29

Statistical Data
1. Number of pharmacists____ (year)
2. Number of GMP inspector (National & Local) 12(year-2016)
3. Number of pharmaceutical manufacturers /manufacturing sites 77 (year-2016)
4. Number of traditional medicine manufacturers /manufacturing sites Not regulated byAct101 (year2016)
5. Number of pharmaceutical importers 171 (year2016)
6. Number of pharmaceutical wholesalers 187 (year30
2016)－ 471 －

flow of reporting side effects-MCC perspective

Medical Institution(ADR forms send via fax or post)

Capturing of Technicalinformation by technical staff

Causality Assessment by
Technical team

NADEMC/Pharmacovigilance
Pretoria office

Quality check by Technical staff
of all the information captured

Commit reports to UMC
Vigibase database

Technical Screening by
Pharmacist(To identify cases that need
immediate attention an where
there is insufficient criticalinformation)

Capturing of ADR forms by
Administrative officers

31－ 472 －

－ 473 －－ 475 －－ 476 －－ 477 －－ 478 －－ 479 －－ 480 －－ 481 －－ 482 －－ 483 －－ 484 －－ 485 －－ 486 －－ 487 －－ 488 －－ 489 －Roles of Regulatory Systems and Pharmacists
on Ensuring Proper Access to Quality
Assured Medicines
Caroline Yuki Nishikawa Nagayama
Specialist in Regulation and Health Surveillance
Brazilian Health Regulatory Agency (ANVISA)
July, 2016

ANVISA Organizational Chart

Created in 1999 by a law(Lei nº 9782/1999)－ 490 －

Legislation on
pharmaceutical administration• National levelLaw 6360/1976
Decree 8077/2013
Resolution RDC 60/2014• Local level
27 state governments that have their own legislation,
considering they don’t differ or contradict the national laws

• PIC/S
GMP – 2018/2019
GCP – 2015/2016: inspections with England and Austria

Drug Import and Export
DRUG IMPORT- Every drug must be registered at Anvisa (RDC 81/2008)- The company must have Anvisa’s authorization to operate- The imported drug must be approved in its country of origin- Natural persons are allowed to import drugs not approved
just for personal use (RDC 28/2011)
DRUG EXPORT- There is no regulation for drug export- Anvisa issues export certificates that the product is approvedin Brazil－ 491 －

Pharmaceutical Manufacturing
GOOD CLINICAL PRACTICE- RDC 09/2015: regulates the conduction of clinical trials withdrugs in Brazil. Incorporates ICH E6 guideline- The inspections evaluate the clinical research centers’
systems, the ethical documents, the case report forms.
- Based on the risk, the number of patients recruited and after
a complaint
GOOD MANUFACTURING PRACTICE- National pharmaceutical manufactures – decentralized
inspections- International pharmaceutical manufacturers – CBPF (GMP
certificate) valid for 2 years. Frequency: risk-based.
- RDC 17/2010 (GMP for drugs)

Marketing Authorization
SYSTEM- Electronic registration (Registro eletrônico – RE)DOSSIER ANALYSIS- GRMED: pharmaceutical technology- RDC 16/2007 (for generic drugs)- RDC 17/2007 (for similar drugs)- RDC 31/2010 and RDC 37/2011 (bioequivalence for generic and similardrugs)- RDC 60/2014 (for new synthetic and semi-synthetic drugs)- GESEF: safety and efficacy (clinical and non-clinical trials
reports)- RDC 60/2014－ 492 －

Drug Distribution and Drug Pricing
DRUG DISTRIBUTION- Unified Health System (Sistema Único de Saúde – SUS)
- Ministry of Health’s attribution
DRUG PRICING- Law 10.742/ 2003: created the Drug Market Regulation
Chamber (CMED)-CMED establishes criteria of drug prices definition and adjustments
ANVISA has the attribution of the Executive Secretariat in the CMED
It’s available at Anvisa’s website (http://portal.anvisa.gov.br/consulta-lista-de-preco-demedicamento) a list with the ceiling prices, the maximum price allowed for a drug
There is a different price-cap established for the public sector

Medicine Safety
POST-MARKETING PHARMACOVIGILANCE- Voluntary reporting of AE by health practitioners and patients- Web form available at Anvisa’s website- The health surveillance reporting system is called- Anvisa is a WHO member, being the national pharmacovigilance
center- RDC 04/2009: regulates how the pharmacovigilance should bedone by the marketing authorization holders (MAH)
RELIEF SYSTEM FOR ADVERSE DRUG REACTIONS- Anvisa’s website- MAH’s letter to the health practitioners－ 493 －

Statistic Data
1. Number of pharmacists
176.963
pharmacistsinBrazil(Source:
http://ictq.com.br/portal/estatisticas-do-setor-farmaceutico/censodemografico-farmaceutico, January, 2014)
2. Number of GMP inspector
National: 28 inspectors (Source: Anvisa, June/2016). We don’t havethe number of local inspectors (municipal and state government
inspectors).
3. Number of pharmaceutical manufacturers
914 national pharmaceutical manufacturers (Source: Anvisa,
May/2016)
4. Number of traditional medicine manufacturers
We don’t have this statistic number.
5. Number of pharmaceutical importers
992 importers (Source: Datavisa - Anvisa, 2015)
6. Number of pharmaceutical wholesalers
6583 wholesalers (Source: Datavisa – Anvisa, 2015)

Side Effect Report
AE

Medical institution

MAH
AE reported byhealthprofessionals

ANVISA (Notivisa)

5 days: death
15 days: SAE

Risk-assessment－ 494 －

7 days: SAE (death/ riskof death)
15 days: others SAE
RDC 04/2009

－ 495 －Roles of Regulatory Systems andPharmacists on Ensuring Proper Accessto Quality Assured Medicines(JFY 2016)
DANIEL NII AMOO ANKRAH
KORLE-BU TEACHING HOSPITALACCRA, GHANA

BACKGROUND OF THE KORLE-BU TEACHING HOSPITALThe Korle-Bu Teaching Hospital was established in 1923 as a 192 bed hospital.
This was under the direction of Sir Gordon Guggisberg, the then British governorof the Gold Coast, now Ghana. The Hospital became a teaching hospital as aresult of the establishment of the Ghana Medical School in 1962.
Today the Hospital has a bed capacity of 2000 and 21 clinical and diagnostic
departments. It has three centers of excellence namely National Cardiothoracic
Center, National Center for Radiotherapy and Nuclear Medicine, and National
Reconstructive Plastic Surgery and Burns Center. It has a staff capacity of about
4000 at the moment.
The Hospital is guided by a board appointed by the president of Ghana and ismanaged by a chief executive and seven directors.

－ 497 －

.
•.

Mission and Vision statement of KBTH
Mission: “We are committed to provide quaternary health care facilities
and services, training, research, outreach and advocacy for clients within
and outside Ghana”.
Vision: “To become the preferred center of excellence and innovation for
specialist health care provision, training, research and advocacy in Ghana
and West Africa”.

－ 498 －HEALTH SYSTEM IN GHANA - 1
Ministry of HealthResponsible for:A. Policy Formulation
B. Monitoring and Evaluation
C. Resource Mobilization
D. Regulation of the Health Services Delivery.
Its autonomous agencies are responsible for implementationof national policies through their governing Councils.
• The agencies receive public funds and thus remain within the
public sector

HEALTH SYSTEM IN GHANA 2
Ministry of Health Agencies
o Ghana Health serviceo National Health Insurance Authority
o National Ambulance serviceo Teaching Hospitals - 4 in the countryo Christian Health Association of Ghanao Health Regulatory Bodies on professional standards









Pharmacy Council,
Food and Drug Authority
Medical and Dental Council
Nurse and Midwives Council
Health Facilities Regulatory Agency
Traditional and Alternate medicine Council
Psychology Council
Allied Health Council

o The centre for scientific research into plant medicine (CSRPM)－ 499 －HEALTH SYSTEM IN GHANA 3
Some Ghana’s development Partners in Health• WHO• UNICEF• Japan International Cooperation Agency -JICA• Department for International Development - DFID
• Danish International Development Agency - DANIDA• GLOBAL FUND
• World Health Organisation - WHO• United Nation Development Programme – UNDP
• UNAIDS, USAID

Administrative Structure of Pharmaceutical Services - 1.0
Ministry of Health(Minister)

Deputy Minister of Health

MOH Directorate

Food and Drugs
Authority

Certification of products

Pharmacy Council
Practice standards&
Registration of
Practitioners

Ghana HealthService

Regional Hospitals
Deputy Director of
Pharmaceuticalservices

District Hospitals
Principal Pharmacist

PrivatePharmacies

Christian
HealthAssociati
on of
Ghana

Teaching Hospitals
Director of
Pharmacy(CHG)

Sub – District
Hospitals
Senior Pharmacist

Health Centres
Community
Health planning
Service (CHPS)－ 500 －

Pharmacy
Department

National
HealthInsurance
Authority

PARASTATAL
Police, Military, SSNIT,
Cocoa Hospitals(Agencies)

Administrative organogram of Korle-Bu Teaching Hospial
KORLE-BU TEACHING HOSPITAL BOARD

CHIEF EXECUTIVE OFFICERSPECIAL ASSISTANT TO CEOINTERNAL AUGITOR
POLICY PLANING MONITORING & EVALUATIONMEDICAL AFFAIRSDIRECTORATEADMINISTRATIONDIRECTORATENURSINGDIRECTORATEFINANCE
DIRECTORATE

PHARMACY
DIRECTORATEHUMANRESOURCE
DIRECTORATE

GENERALSERVICES
DIRECTORATE

Administrative Structure of Pharmaceutical Services - 1.1
 In the Public sector, Medicines are categorised intolevel of care and are accessed accordingly: from thelower level Community Health planning Services(CHPS), Health Centre, sub district health facility,
District hospital, Regional, and Referral/Teaching
hospitals in ascending order.
 Mostly non- prescription medicines are available atthe sub district level and in the rural areas
No person deals in restricted medicines unlesshe/she is registered with Pharmacy Council
The Pharmacy Council licenses the private pharmacies－ 501 －

ROLES OF PHARMACISTS IN MEDICINEREGULATION 1.2

It is recognised that certified medicine by Food andDrugs Authority that are safe , efficacious, and of goodquality in the hands of unqualified persons can poserisk to the public, thus the role of a pharmacist in
medicine regulation is vital;• Detecting, identification of substandard, spurious,
falsely labelled, falsified and counterfeit (SSFFC)
medicines in supply and distribution chains andreporting to Food and Drugs Authority for appropriate
action• Post – marketing safety issues: Detecting andreporting ADR to Food and Drugs Authority• Manage properly supply chain and inventory control of
medicines to ensure constant availability of Essential
Medicines

ROLES OF PHARMACISTS IN
MEDICINE REGULATION - 1.3• They take into custody, preparation and dispensing of
medicines• Selection and provision of prescription and non-prescription
medicines to patients from private retail pharmacies• Ensure safe and rational use of medicines• Lead in medicine Policy and hospital formulary formulation• Provide information on medicine to other healthprofessionals• Provide clinical service to all deserving patients• Play an active role on Drugs and Therapeutic Committees• Perform operational research, involve in clinical trials－ 502 －LEGISLATIONS REGULATING ACCESS TO MEDICINES IN GHANA - 2
legislation /ActCONSTITUENTSTATUS OF
LI

The Health Professions Regulatory Bodies Act, 2013 (Act857)

Pharmacy Council

LI Pending

Traditional Medicine Practice Act 2000 (Act 575)

Traditional andAlternative Medicine
CouncilPublic Health Act 2012, Act 851

Food and Drug
Authority

Outstanding

Health Institutions and Facilities Regulatory Act 2011
(Act 829)

Health facilities
Regulatory Agency

Submitted to
AG Depart

National Insurance Authority Act 2012 (Act 852)

National Health
Insurance Authority

Pending tosubmitted to
AG DepartSpecialist Health Training & Plant Medicines Research
Act 833

Ghana college of
Pharmacist &PendingGhana National Medicine policy (GNDP) 3rd edition

Centre for plant
Medicine Researchcompleted

GNDP & Ministry of
HealthSubmitted
to Cabinet

REGULATORY FUNCTIONS – 3
Verification elements• MOH (all levels)• Public (companies, professionals, NGOs, press)

Administrative elements• Organizational Structure• Human resources• Financing• Planning, monitoring,evaluation

Regulatory functions
Regulation is an
essential state function
Licensing
persons andcompanies

Technical elements
of products - FDA• Standards• Specifications• Guidelines/Norms

HEALTH INSTITUTION &FACILITIES REGULATORYAGENCY

Licensing ofpremises• Policy, legislation, regulations

Informationand control ofpromotion
andadvertisingMarketingauthorization (registration)

Inspection:
manufacturers, distribution,
Clinical Trials
sites

Authorization ofclinical trials

Licensing ofpractitioners ;competency & fitness
to practice ,Monitoring ofMedicines distribution
outlets

Monitoringsafety ofMedicines in,supply chain
systems for
quality of
Medicines

Levels• Central• Intermediate• District• Community• Procedures• Certification

Monmission2010－ 503 －

Practice elements
Practice & Premisestandards

Pharmacy Council

14

MEDICINE REGULATION IN GHANA

Food and Drugs Authority ( FDA)

• By the law medicines must be registered by FDA before distribution
and use in Ghana• Product assessment and registration programme thus constitute thehub of FDA regulatory function:o Evaluation of technical and administrative data associated withproductso Laboratory testing or analysiso Decision to approve or disapprove of products
o Issuance of market authorisationo Issuance of import permito Conducting ADR monitory on medicines
This is to ensure that registered products have been adequately
tested and evaluated for safety, efficacy and quality that information
provided to the patients is accurate and not misleading

MEDICINE REGULATION IN GHANA
Pharmacy Council

By Health Professions Regulatory Bodies Act, 857 part V & VI, any person whopractice pharmacy in Ghana must be registered. This is to ensure in the public
interest the highest standards of pharmacy practice in the country, Thus:
The primary regulatory functions of the Pharmacy Council includes:• Register pharmacist and Pharmaceutical support staff• Set standards for continuous professional development for Pharmacists• Ensure the equitable and accessible distribution of pharmaceutical premises• Set and maintain standards for pharmacy practice and professional conduct• Register , Monitor and evaluate medicines distribution outlet to ensure thatset standards /quality of medicines are complied with
• Exercise disciplinary power over pharmacists and pharmaceutical support staff－ 504 －

Drug import/export 3.1
Drug (including active pharmaceutical ingredients) importation and exports
are regulated and controlled by:• The FDA• Ministry of Trade• Customs Excise and Preventive Service.
Where narcotic drug importation is involved, the Narcotics Control Board isalso involved. For example, the KBTH imports Morphine for the preparationof Morphine Sulphate solution.

Pharmaceutical Manufacturing 3.2
The manufacturing premises as well as production and process are
regulated by the FDA Ghana. The FDA Ghana trains personnel on Good
Clinical practice (see below). They also ensure that Good Manufacturing
Practices (GMP) are adhered to by all manufacturers.
The Ghana Standards Authority inspects equipment through their
Metrology Division and maintains standards.
The qualified personnel to register the manufacturing facility is regulated by
the Pharmacy Council.

－ 505 －

Marketing Authorization (MA) 3.3
The FDA Ghana has a separate division for Safety Monitoring and Clinical
Trials of products. They regulate all phases of clinical trials involving
medicines in Ghana. The FDA is the only body in Ghana responsible for
issuing MA to any pharmaceutical manufacturer or importer.

Drug selection, procurement and sale 3.4
Drug selection is done by the Ghana National Drugs Programme incollaboration with all health stakeholders (clinicians, pharmacists, nurses).

Drug procurement is done with the guidance of the Public Procurement
Act, Act 663 (2003).
Ghana has an open market system and there is no price control on the saleof medicines.

－ 506 －

.

Medicine Safety (post-marketing surveillance) 3.5. 1. Safety Monitoring and Clinical Trail Division of the Food and Drugs

Authority responsible for post marking surveillance.
2. Two Technical advisory committees on: i. Medicines and ii. vaccines andbiologicals products which review ADR cases reported.
3. Systems of reporting by filling the Blue form and returning them ( it isvoluntary)• Health professional in health facilities – ADR• Patients – side effects of medicines
4. Feed back in writing to reporters/institutions

Relief System for Adverse drug Reaction 3.6
Drug-related iatrogenic diseases, when they occur, are reported to FDA Ghana.
The reporting institution takes care of the patient naturally (as if it were anormal disease occurrence).
If the person has registered with the National Health Insurance Authority, freeservices are provided.
There is no special relief package in the form of regulation in Ghana at the
moment for such situations.

－ 507 －

MEDICINES PRICING - 4.0• The Ministry of Health (MOH) has no pricing policy• MOH Centrally Procures Anti –retroviral ( ARVs), psychotropic, familyplanning products, anti-tuberculosis drugs and vaccines throughvoluntary pooled procurement from Global Fund and Global Drug
Facility (GDF) and supply them supplied free. (Programme medicines)• Essential medicines are procured by the Central and Regional
Medical Stores, Tertiary and district facilities directly• National Insurance Scheme coverage is about 80 – 95 % ofconsultations in public facilities• Over 50 % National Insurance Scheme expenditure is on medicines• Affordability 62 % of the population• Facilities prices tends drift towards the reimbursement price of
National Insurance Scheme• The proportion of uninsured patients that are willing to pay extra fornon . EML is about 2 %MEDICINES PRICING IN GHANA 4.1
PRICE C0MPONET OF MEDICINES ( OUT – POCKET PAYMENT & NHIS)
 In public facilities the mark up is 12% - 20%
 Import duty 10 % of CIF and VAT 17.5 %, Tariffs; port rent, handling and clearing agent fees Mark-up ; importers typically added up 36 % ex – factory price.
medicines and retailers - 30 %, a levy of 2.5 % on goods and services are charge for NHISPaediatric formulations are more expensive than adult formulations .
Paracetamol syrup is 400 % more expensive than the respective tablet－ 508 －STATISTICAL DATA – 5.0
Facility

Number As at 31 Dec. 2015

Pharmacist ( Practising )2578

GMP inspectors

27

Pharmaceutical manufactures

39

Traditional medicine manufactures

100

Importers

38

Pharmaceutical wholesalers

235.

INFORMATION ON PHARMACISTS AND
PHARMACY PRACTICE AT THE KORLE-BU
TEACHING HOSPITAL 6.0－ 509 －Mission and Vision Statement of the Pharmacy Department
Mission: “To ensure acquisition and supply of safe medicines, promote
cost-effective medication use, and work synergistically with health carecolleagues to stimulate optimal drug therapeutic outcomes through thedevelopment of integrated quality programs in patient care, researchand education”.
Vision: “To ensure that the Pharmacy Directorate is envisaged as aleader in providing optimal pharmaceutical expertise, innovation andpersonalized care to (patients) clients who visit the Korle-Bu Teaching
Hospital”.

DIRECTOR OF PHARMACYDEPUTY DIRECTOR
OF PHARMACY

Sub-BMC /Satellite
Pharmacies(Out – and Inpatient Services)
















Research,
Pharmacovigilance& Quality
Assurance Unit

24-Hour Pharmacy
Medical Pharmacy
Emergency Pharmacy
Accident Centre Pharmacy
Surgical Pharmacy
Obstetrics & Gynae Pharmacy
Child Health Pharmacy
Chest Clinic Pharmacy
Polyclinic Pharmacy(Clinical
Genetics )Reconstructive Plastic Surgery andBurns Centre Pharmacy
Adherence Counselling Unit
Cardiothoracic Pharmacy*
Radiology Dept (Contrast
support)*Radiotherapy Centre (HRsupport)*StoresManagement
Unit

Clinical/Ward
Pharmacy andTraining Unit

Drug
Information
Unit

Statistics
Monitoring &Evaluation Unit

Manufacturing/ Quality
Control Unit

Inventory Monitoring &Control
Procurement Unit
Accounts( Monitoring &Costing)Finance

Production Unit
Pharmaceutical
Analysis Unit
New
Formulations

ORGANOGRAM OF PHARMACY DIRECTORATE,KORLE BU TEACHING HOSPITAL－ 510 －

PHARMACY MANAGEMENT STAFF 6.1

Director of Pharmacy

1

Deputy Director of Pharmacy

1

Pharmacy Managers

17

Number of Pharmacy Staff 6.2
Number of Pharmacists (Total)84

Number of clinical pharmacists

20

Number of Public Health Pharmacists

7

Number of Pharmacy Technicians34－ 511 －

Number of kinds of drugs managed at the Korle-Bu Teaching Hospital 6.3

Oral medicines (tablets, syrups and suspensions)

385

Injections (including anaesthetic agents)

156

Medicines for external use (eye, ear, nose, creams and ointments)

71

Number of prescriptions dealt with per day 6.4

For in-patients137

For out-patients

1,091－ 512 －

Equipment of the Pharmacy at the Korle-Bu Teaching Hospital 6.5
A/ Presence of dispensary room
 8 dispensaries in all
B/ Presence of lamina flow

Yes

C/ Presence of computers
All the dispensaries use computers

Yes

D/ Therapeutic drug monitoring
E/ Preparation of Total Parenteral
Nutrition (TPN)
F/ Internet at the pharmacy

NoNo

18-150 m3(smallest to largest)
3
a. Oncology admixturesb. Radiopharmacy
c. Manufacturing Unit
• Inventory control• Drug billing• Dispensing• Internet accessYes

We use preformed TPN• For drug information purposes• Computer communication• Accounting purposes

Yes

Pictures of the largest pharmacy at the KBTH

－ 513 －EDUCATION AND LICENSING OF PHARMACISTS GHANA -7.0
Schoolyears

Primary school

6

Junior secondary

3

Senior secondary school

3

University

4 For Bsc
6 For doctorate in Pharmacy

Internship training
A. Accredited Public hospital for clinicalpractical training
B. Accredited Private pharmacy

Total years
in school

9 months
3 months

BSc Pharmacy to be phased out by 2018

Proposed Internship for Doctorate ofpharmacy

40 weeks in hospital for graduates of doctorate inPharmacy. (students in the fourth year)

Ghana Pharmacy Professional Qualifying
Examination

December and April annually

PHARMACY TRAINING INSTITUTIONS -7.1
Name of university

An average turn out of graduates per year

Kwame Nkrumah University of Science &Technology

250

University of Ghana School of Pharmacy

40

Central University College

90

Ghana Post – Graduate college of
Pharmacists for specialist training

First 150 graduates are expected in 2018

Total

380

－ 514 －

17
( 19 fordoctorateinPharmacy)

Twice in ayear

PHARMACISTS LICENSED FOR THE PAST THREEYEARS - 7.2
year

Number licensed

2014

207

2015

199

2016

350

Total

756

Average per a year

252

Side effect report at the Korle-Bu Teaching Hospital 8.0
In the event of a severe side effect of a drug or herbal preparation, there are two ways toreport. The first is that the reporting health personnel (doctor, pharmacist or nurse) fills theapproved "blue form" (see next slide). This form is then submitted to the Safety Monitoring
and Clinical Trials Division of the Food and Drugs Authority (FDA) Ghana. The form is
submitted either by direct posting to FDA (their address is behind the form) or by informing
them via telephone, and someone will be sent to collect it as soon as possible. The second
option is to submit the report online. Online submission is done by visiting the FDA's website(www.fdaghana.gov.gh). However, one needs a username and password to send a form
online. This username and password is provided by the FDA upon application. When the FDA
receives the form, they give two responses. Firstly, a letter of acknowledgement is written to
sender. At the FDA, a preliminary assessment of the report is made. For serious reports aninvestigation is made within 48 hours of receiving it. The details of the report is then enteredinto the national database. Then the form is sent to the Technical Advisory Committee (TAC)on safety of medicines of the FDA for causality assessment. When findings are made, asecond letter is sent to the sender of the form informing him/her on the outcome of thereport. After causality assessment by the TAC, the form is submitted to the Vigiflow
database. This is a web-based Individual Case Safety Report (ICSR) management system thatis specially designed for use by national centres in the World Health Organization (WHO)Programme for International Drug Monitoring. The center is at Uppsala in Sweden. A flow
chart of the process is attached.

－ 515 －

Reporting form and flow chart for reporting adverse reactions in Ghana by health professionals.

－ 516 －

Roles of Regulatory Systems andPharmacists on Ensuring Proper Access to
Quality Assured Medicines （JFY 2016）
PART 2
Name: Daniel Ankrah
Country: Ghana
Organization/Department: Korle-Bu Teaching Hospital

Demography of Ghana－ 517 －

Organization and department
Korle-Bu Teaching Hospital (1923) established by the British• A 2000 bed hospital with 17 clinical and diagnostic departments
including the department of pharmacy• 3 Centres of clinical excellenceNational Cardiothoracic Centre
National Centre for Radiotherapy and Nuclear Medicine
National Reconstructive Plastic Surgery and Burns Centre

Organization and department cont.
Pharmacy department
Job tenure : 1/10/1991 – Houseman pharmacist
1/01/1993 – Assistant pharmacist
1/02/1996 – Pharmacist
1/03/2001 – Senior pharmacist
4/03/2006 – Principal pharmacist
4/03/2011 – Deputy Director of Pharmaceutical Services
4/01/2016 – Ag Deputy Director of Pharmacy
15/07/2016 – Still at post

－ 518 －

Role and position of pharmacists in Ghana
Government employee
Academia – lecturer/researcher
Health programmeMental HealthNational Malaria Drugs ProgramNational AIDS Control Programme

Private employee/employer
Community (retail) practiceIndustry
Medical Representative
Wholesale supplier/distributor

National tuberculosis control programmeExpanded programme on immunization

HospitalGhana Health Service
Teaching Hospital

Regulatory agency
FDA Ghana/Pharmacy Council

Any of the United Nation’s bodies (WHO)Regulatory services performed• Institutional contact person for safety of medicines• Member of the Technical Advisory Committee on Biological Products andVaccines, FDA Ghana• Member of the Korle-Bu Teaching Hospital Ethical Review Committee• Oversees the Local Manufacturing Unit of the KBTH
• Heads the Pharmacy Practice Research Unit of the Pharmacy Department－ 519 －

.

.Good practices: Achievements, solutions for the past

Good practices: On-going projects to deal with current problems• Reporting of adverse events following immunizations in Ghana- Using disproportionality analysis reporting ratios – Research• Audit of the new prescription form to improve access to
medicines through rational prescribing - Research－ 520 －

.Difficult lessons learned from past experience• Hospital Drugs and Therapeutic Committees (DTC) and FDA Ghana havetrained health care professionals on identification and reporting of
spontaneous adverse events but the outcomes are not improving• Availability of a hospital formulary, Essential Medicines list and Standard
Treatment Guidelines; training on the use of these documents are provided
periodically. However, we still see prescriptions that are not in these
documents. What are we not doing right? Communication?

Expectations by the end of this program
1. To learn best practices that will encourage spontaneous reporting ofadverse events of medicines by health care professionals
2. To learn what other countries doing right in generic prescribing,because it reduces cost and improves access to medicines. “Genericparadox”
3. Find out more on off-label prescribing of medicines since there isevidence that it is associated with unknown adverse events.

－ 521 －

PART I
Roles of regulatory systems andpharmacists on ensuring proper
access to quality assured medicines(JFY 2016)
HENRY SAJA MADEN
GHANA
PHARMACY COUNCIL, GHANA

GHANA - 1
Ghana, officially called the Republic of Ghana is a sovereign, unitarypresidential constitutional democracy• located along the Gulf of Guinea , in the sub region of West Africa withland mass of 238,535 square km• Ghana is bordered by the Ivory Coast in the west, Burkina Faso in thenorth, Togo in the east and Atlantic Ocean in the south.
• Ghana has a population of approximately 27 million• Ghana is one of the world's largest producer of gold and second
producer of cocoa.
• Religiously, 5.2% of the population is traditional religion, 71.2% are
Christian and 17.6% of the total are Muslim.

－ 522 －

GHANA ON THE WORLD MAP

GHANA ON WEST AFRICA MAP－ 523 －

MAP OF GHANA

PHARMACY COUNCIL, GHANA
VISIONTo guarantee the highest levels of pharmaceutical care

MISSION STATEMENT
The mission of the Pharmacy Council, Ghana is to secure the highest
level of pharmaceutical care by ensuring competent pharmaceuticalcare providers who practice within agreed standards and are accessible
to the whole population. In addition we shall collaborate with related
local agencies and international pharmaceutical organizations toenhance our effectiveness and our contribution to rational medicine
use in the nation. This mission shall be carried out with dedication,
integrity, and professionalism.

－ 524 －

PHARMACY COUNCIL, GHANA
The Pharmacy Council of Ghana is a statutory regulatory bodyestablished by an act of parliament , the Health Professions Regulatory
Act , 2013 ( Act) 857 , part 4 and 6 . The objective of the Council is tosecure in the public’s interest, the highest standards of pharmaceuticalcare in Ghana.

PHARMACY COUNCIL -MINISTER OF HEALTHORGANOGRAM

GOVERNING BOARD
REGISTRARHEAD OF FINANCE

DEPUTY REGISTRAR, Professional Development

TRAINING AND
EDUCATION

REGN & LIC

Accreditation

Registration of
Practitioners

Examinations
Training
Research

INTERNAL AUDITORPRIVATE SECRETARY

Licensing ofPharmacies
Renewal ofLicences

HEAD OFADMINISTRATION/HR

DEPUTY REGISTRAR, Operations

LEGAL
DEPARTMENTMONITORING &ÊVALUATIONMIS/PUBLICATION

Personnel

General Counsel

Planning

Mgt Information

EstatesComplaints &Investigations

Monitoring &Evaluation

Publications

Supplies
Transport
StoresDisciplinary &Prosecutions
DisputeResolution

Pub. Relations
REGIONAL/ZONALMANAGERS
Deputy Manager

Housekeeping

Accountant

Security

Security
Private Secretary
DriverDriveret－ 525 －

Induction of New Pharmacists

HEALTH SYSTEM IN GHANA - 1
Ministry of HealthResponsible for:A. Policy Formulation
B. Monitoring and Evaluation
C. Resource Mobilization
D. Regulation of the Health Services Delivery.
Its autonomous agencies are responsible for implementationof national policies through their governing Councils.
• The agencies receive public funds and thus remain within the
public sector－ 526 －HEALTH SYSTEM IN GHANA 2
Ministry of Health Agencies
o Ghana Health serviceo National Health Insurance Authority
o National Ambulance serviceo Teaching Hospitals - 4 in the countryo Christian Health Association of Ghanao Health Regulatory Bodies on professional standards









Pharmacy Council,
Food and Drug Authority
Medical and Dental Council
Nurse and Midwives Council
Health Facilities Regulatory Agency
Traditional and Alternate medicine Council
Psychology Council
Allied Health Council

o The centre for scientific research into plant medicine (CSRPM)

HEALTH SYSTEM IN GHANA 3
Some Ghana’s development Partners in Health• WHO• UNICEF• Japan International Cooperation Agency -JICA• Department for International Development - DFID
• Danish International Development Agency - DANIDA• GLOBAL FUND
• World Health Organisation - WHO• United Nation Development Programme – UNDP
• UNAIDS, USAID－ 527 －ADMINISTRATIVE STRUCTURE OF PHARMACEUTICAL SERVICES - 1.0
Ministry of Health(Minister)

Food and Drugs
Authority

Certification of products

Pharmacy Council:
Practice standards &Registration of
Practitioners

Ghana HealthService

Regional Hospitals
Deputy Director of
Pharmaceuticalservices

District Hospitals
Principal Pharmacist

PrivatePharmacies

Christian
HealthAssociati
on of
Ghana

Teaching Hospital
Director of
Pharmaceuticalservices

National
HealthInsurance
Authority(CHG)

Sub – District
Hospitals
Senior Pharmacist

Health Centres

Pharmacy Units

PARASTATAL
Police, Military,
SSNIT, Cocoa
Hospitals

Community
Health planning
Service

ADMINISTRATIVE STRUCTURE OF
PHARMACEUTICAL SERVICES - 1.1

 In the Public sector, Medicines are categorised intolevel of care and are accessed accordingly: from thelower level Community Health planning Services >Health Centre > sub district health facility > District
hospital > Regional > Referral/Teaching hospitals thehighest level only Non- prescription medicines are available atthe sub district level and in the rural areas
No person deals in restricted medicines unlesshe/her is registered with Pharmacy Council
The Pharmacy Council licenses the private pharmacies－ 528 －

Central
MedicalStore

Regional
MedicalStore

ROLES OF PHARMACISTS IN MEDICINEREGULATION 1.2

It is recognised that certified medicine by Food andDrugs Authority to be Safe , efficacious, and of goodquality in the hands of unqualified persons can poserisk to the public, thus the role of a pharmacist in
medicine regulation is vital;• Detecting, identification of falsified and sub standard
medicines in supply and distribution chains andreporting to Food and Drugs Authority for appropriate
action• Post – marketing safety issues: Detecting andreporting ADR to Food and Drugs Authority• Manage properly supply chain and inventory control of
medicines to ensure constant availability of Essential
Medicines

ROLES OF PHARMACISTS IN
MEDICINE REGULATION - 1.3• The take into custody, preparation and dispensing of
medicines• selection and provision of non-prescription medicines topatients from private retail pharmacies ( 2,165 in the
country)• Ensure safe and rational use of medicines• Lead in medicine Policy formulation• Provide information on medicine to other healthprofessionals－ 529 －LEGISLATIONS REGULATING MEDICINES SUPPLY IN GHANA - 2
legislation /ActCONSTITUENTSTATUS OF
LI

The Health Professions Regulatory Bodies Act, 2013 (Act857)

Pharmacy Council

LI Pending

Traditional Medicine Practice Act 2000 (Act 575)

Traditional andAlternative Medicine
CouncilPublic Health Act 2012, Act 851

Food and Drug
Authority

Outstanding

Health Institutions and Facilities Regulatory Act 2011
(Act 829)

Health facilities
Regulatory Agency

Submitted to
AG Depart

National Insurance Authority Act 2012 (Act 852)

National Health
Insurance Authority

Pending tosubmitted to
AG DepartSpecialist Health Training & Plant Medicines Research
Act 833

Ghana college of
Pharmacist &PendingGhana National Medicine policy third edition

Centre for plant
Medicine Researchcompleted

GNDP & Ministry of
HealthSubmitted
to Cabinet

REGULATORY FUNCTIONS – 3
Verification elements• MOH (all levels)• Public (companies, professionals, NGOs, press)

Administrative elements

Licensing ofpremises• Policy, legislation, regulations• Organizational Structure• Human resources• Financing• Planning, monitoring,evaluation

Regulatory functions
Regulation is an
essential state function
Licensing
persons andcompanies

Technical elements
of products - FDA• Standards• Specifications• Guidelines/Norms

HEALTH INSTITUTION &FACILITIES REGULATORYAGENCY

Informationand control ofpromotion
andadvertisingMarketingauthorization (registration)

Inspection:
manufacturers, distribution,
Clinical Trials
sites

Authorization ofclinical trials

Licensing ofpractitioners ;competency & fitness
to practice ,Monitoring ofMedicines distribution
outlets

Monitoringsafety ofMedicines in,supply chain
systems for
quality of
Medicines

Levels• Central• Intermediate• District• Community• Procedures• Certification

Practice elements
Practice & Premisestandards
Monmission2010－ 530 －

Pharmacy Council

19

MEDICINE REGULATION IN GHANA – 3.1
Food and Drugs Authority ( FDA)

• By the law medicines must be registered by FDA before distribution
and use in Ghana• Product assessment and registration programme thus constitute thehub of FDA regulatory function:o Evaluation of technical and administrative data associated withproductso Laboratory testing or analysiso Decision to approve or disapprove of products
o Issuance of market authorisationo Issuance of import permito Conducting ADR monitory on medicines
This is to ensure that registered products have been adequately
tested and evaluated for safety, efficacy and quality that information
provided to the patients is accurate and not misleading

MEDICINE REGULATION IN GHANA – 3.2
Pharmacy Council ( PC)

By Health Professions Regulatory Bodies Act, 857 part V & VI, any person whopractice pharmacy in Ghana must be registered. This is to ensure in the public
interest the highest standards of pharmacy practice in the country, Thus:
The primary regulatory functions of the Pharmacy Council includes:• Register pharmacists and Pharmaceutical support staff• Set standards for continuous professional development for Pharmacists• Ensure the equitable and accessible distribution of pharmaceutical premises• Set and maintain standards for pharmacy practice and professional conduct• Register , Monitor and evaluate medicines distribution outlet to ensure thatset standards /quality of medicines are complied with
• Exercise disciplinary power over pharmacists and pharmaceutical support staff• Ensure that the education and training of pharmacists and pharmaceuticalsupport staff are carried out in approved educational institutions－ 531 －DRUG IMPORT/EXPORT 3.3
Drug (including Active Pharmaceutical Ingredients (API) importation and exports are regulated andcontrolled by:
The FDA in collaboration with Ministry of Trade andCustoms Excise and Preventive Service.
Where narcotic drug importation is involved, theGhana Narcotics Control Board is also involved.

PHARMACEUTICAL MANUFACTURING 3.4
The manufacturing premises as well as production andprocess are regulated by the FDA Ghana. The FDA Ghana
trains personnel on Good Clinical practice (see below).
They also ensure that Good Manufacturing Practices (GMP)
are adhered to by all manufacturers.
The Ghana Standards Authority inspects equipment
through their Metrology Division and maintains standards.
The qualified personnel to register the manufacturing
facility is regulated by the Pharmacy Council.

－ 532 －MARKETING AUTHORIZATION (MA) 3.5
The FDA is the only body in Ghana responsible for
issuing MA to any pharmaceutical manufacturer orimporter.
The FDA Ghana has a separate division for Safety
Monitoring and Clinical Trials of products. They
regulate all phases of clinical trials involving medicines
in Ghana.

GOOD DISTRIBUTION PRACTICES - 3.6
 Any person who practice pharmacy in Ghana must be
registered.
 Availability of non prescription medicines outlets in
the rural areas
No medicine is offered for dispensing in Ghana unless

it is registered by Food and Drugs Authority
The current policy of MOH allows herbal medicines tobe prescribed and dispensed in the hospitals
Medicines are permitted to be dispensed from only

registered premises－ 533 －DRUG SELECTION, PROCUREMENT AND SALE 3.7
Medicines selection is done by the Ghana National Drugs
Programme in collaboration with all health stakeholders(clinicians, pharmacists, nurses).
 medicines procurement is done with the guidance of the
Public Procurement Act, Act 663 (2003).
Ghana has an open market system and there is no pricecontrol on the sale of medicines.

MEDICINES PRICING - 4.0• The Ministry of Health (MOH) has no pricing policy• MOH Centrally Procures Anti –retroviral ( ARVs), psychotropics, familyplanning products and vaccines through voluntary pooled
procurement from Global Fund and Global Drug Facility (GDF) andsupply them supplied free. (Programme medicines)• Essential medicines are procured by the Central and Regional
Medical Stores, Tertiary and district facilities directly• National Insurance Scheme coverage is about 80 – 95 % ofconsultations in public facilities• Over 50 % National Insurance Scheme expenditure is on medicines• Affordability 62 % of the population• Facilities prices tends drift towards the reimbursement price of
National Insurance Scheme• The proportion of uninsured patients that are willing to pay extra fornon . EML is about 2 %－ 534 －

MEDICINES PRICING IN GHANA 4.1
PRICE C0MPONET OF MEDICINES ( OUT – POCKET PAYMENT& NHIS) In public facilities the mark up is 12% - 20%
 Import duty 10 % of CIF and VAT 17.5 %, Tariffs; port rent, handling and clearing agent fees Mark-up ; importers typically added up 36 % ex –factory price. medicines and retailers - 30 %, a levy of 2.5 % on goods and services are charge for NHISPaediatric formulations are more expensive than adultformulations . Paracetamol syrup is 400 % more expensive
than the respective tablet
Ghana National Medicines Policy 3rd Edition 2016-2020

STATISTICAL DATA – 5.0
Facility

Number As at 31 Dec. 2015

Pharmacist ( Practising )2578

GMP inspectors

27

Pharmaceutical manufactures

39

Traditional medicine manufactures

100

Importers

38

Pharmaceutical wholesalers235－ 535 －REGIONAL DISTRIBUTION OF PRIVATE PHARMACIES – 5.1
NO.

RegionWholesale/Retail Manufacture with wholesale
outlets

Number On
Register

RetailWholesale

1 Ashanti
2 Brong Ahafo
3 Central
4 Eastern
5 Greater Accra
6 Northern
7 Upper East
8 Upper West
9 Volta
10 Western

478
55
55
71
1371
30
13
7
31
78

286
8
27
22
670
13
5
2
11
30

51
3
5
7
141
10
1
0
3
14

98
44
27
35
152
12
6
4
16
33

6
0
0
1
10
0
0
0
0
0

TOTAL

2189

1074

235

437

17

Pharmacy Council annual report 2015

PHARMACY COUNCIL , INSPECTORS – 5.2
Inspectors

Number at post

Registrar

1

Ag. Deputy Registrar

1

Deputy Chief Inspecting Pharmacist

3

Principal Inspecting Pharmacist

8

Senior Inspecting Pharmacist

16

Inspecting Pharmacist

3

Total

32

－ 536 －EDUCATION AND LICENSING OF PHARMACISTS GHANA -7.0
Schoolyears

Primary school

6

Junior secondary

3

Senior secondary school

3

University

4 For Bsc
6 For doctorate in Pharmacy

Internship training
A. Accredited Public hospital for clinicalpractical training
B. Accredited Private pharmacy

9 months
3 months

Total years
in school

BSc Pharmacy to be phased out by 2018

Proposed Internship for Doctorate ofpharmacy

40 weeks in hospital for graduates of doctorate inPharmacy. (students in the fourth year)

Ghana Pharmacy Professional Qualifying
Examination

December and April annually

Registration and issue of number
Continuous Professional Development &Re – licensure ( minimum 10 credit point )Onceannually

PHARMACY TRAINING INSTITUTIONS -7.1
Name of university

An average turn out of graduates per year

Kwame Nkrumah University of Science &Technology

250

University of Ghana School of Pharmacy

40

Central University College

90

Ghana Post – Graduate college of
Pharmacists for specialist training

First 150 graduates are expected in 2018

Total

380

－ 537 －

17
( 19 fordoctorateinPharmacy)

Twice in ayear

PHARMACISTS LICENSED FOR THE PAST THREE YEARS - 7.2
year

Number of Pharmacists licensed

2014

207

2015

199

2016

350

Total

756

Average per a year

252

POST - MARKETING SURVEILLANCE - 8 .0
1. Safety Monitoring and Clinical Trail Division of the Food and Drugs
Authority responsible for post marking surveillance.
2. Two Technical advisory committees on ; 1. Medicines 2. vaccinesand biologicals products which review ADR cases reported.
3. Systems of reporting by filling the Blue form and returning them (it is voluntary)• Health professional in health facilities – ADR• Patients – side effects of medicines
4. Feed back in writing to reporters/institutions－ 538 －RELIEF SYSTEM FOR ADVERSE DRUG REACTION 8.1

 Medicines -related iatrogenic diseases, when they occur, arereported to FDA Ghana. The reporting institution takes care of
the patient naturally (as if it were a normal disease
occurrence).
If the person has registered with the National Health
Insurance Authority, free services are provided.
There is no special relief package in the form of regulation in
Ghana at the moment for such situations.

－ 539 －

GOOD PHARMACOVIGILANCE PRACTICES 8.2
 A division at FDA for Safety Monitoring Safety Monitoring of facilities by team of FDA
inspectors
 Involvement of Patients in reporting side effects ofmedicines to the regulators
 Feed back on cases to reporters/institutions
 Contact persons in health institutions who liaise with
FDA

－ 540 －

PART II
Roles of regulatory systems andpharmacists on ensuring proper
access to quality assured medicines(JFY 2016)
HENRY SAJA MADEN
GHANA
PHARMACY COUNCIL, GHANA

GHANA - 1
Ghana, officially called the Republic of Ghana is asovereign, unitary presidential constitutional
democracy• located along the Gulf of Guinea , in the sub region ofWest Africa• Ghana has a population of approximately 27 million
with a variety of ethnic, linguistic and religious
groups.
• Ghana is one of the world's largest producer of goldand second producer of cocoa.
• National capital Accra－ 541 －

GHANA ON THE WORLD MAP

MAP OF GHANA－ 542 －

PHARMACY COUNCIL , GHANA
VISION: to guarantee the highest levels of pharmaceuticalcare in Ghana
Post : Head of Monitoring and Evaluation Department.
Title : Deputy Chief Inspecting Pharmacist( Equivalent of Deputy Director of pharmaceutical services )Job functions and responsibilities:
 Monitor and Evaluate Pharmacy Council’s inspections andenforcement activities and report to the Governing BoardRecommend and prepare concept paper in the areas ofoperational researchLiaise with other departments and regional offices toprepare annual plans of work and budget

ROLES OF PHARMACISTS IN MEDICINE REGULATION• Detecting, identification of falsified and sub standard medicines insupply and distribution chains and reporting to Food and Drugs
Authority for appropriate action• Post – marketing safety issues: Detecting and reporting ADR to theappropriate Authorities• The take into custody, preparation and dispensing of medicines• selection and provision of non-prescription medicines to patientsfrom private retail pharmacies ( 2,165 in the country )• Ensure safe and rational use of medicines• Lead in medicine Policy formulation• Provide information on medicine to other health professionals• Manage properly supply chain and inventory control of medicines toensure constant availability of Essential Medicines－ 543 －POSITIONS OF PHARMACISTS IN GHANA
Ministry of HealthDirector of Pharmaceutical services(Chief Pharmacist)
Teaching Hospitals
Deputy Director of Pharmaceuticalservices

Ghana Health Service

Regional Hospitals
Deputy Director of Pharmaceuticalservices

District Hospitals
Principal Pharmacist

Sub – District Hospitals
Senior Pharmacist

REGULATORY SERVICES DIRECTLY ENGAGED
lead in monitoring and evaluation of
inspection/enforcement activities in medicines
distribution outlets to drive improvement in set
standards for access to quality medicines inGhana－ 544 －

GOOD PRACTICES 1
TRANSPARENCY : guidelines that explains how ourservices can be accessed and helping duty holders tounderstand what is expected of them and what theyshould expect from the Council.
The problem: Prospective pharmaceutical service
providers turn to middle men for help to obtain permit .
These Men pose as staff of the Council thus undermine
the credibility of our inspectors
led in the review of guidelines ( including application
forms) detailing how to obtain pharmacy operating
licence. The Procedures , processes, requirement andthe responsibility and role of pharmacist. For bothprivate and public pharmacies/dispensary and made itavailable free of charge at the regional office and at our
website. Before then, they were been sold

GOOD PRACTICES - 2

CONSISTENCY in Enforcement : taking asimilar approach in similar circumstances toachieve similar outcomes• The problem: Regional variation in approaches
to inspections and response to incidents andbreaches.
In February 2015 , Led in development ofstandard operating procedures for Routine ,site, Processing of applications for permits－ 545 －

DIFFICULTIES/LESSONS FROM THE PAST EXPERIENCE

The risk management and control approach to regulation
have no effective mechanism for demonstration
improvement in standards –In January 2016. led in redesigning checklist used forinspections in cooperating action plans for improving poor
standards & in service training… Tracking what is needed to
be improved. Emphasis on optimum outcome. That is
improvement rather then minimum standards
Effective pharmacist direct personal control of private
pharmacies had been our problem.
Measures such suspensions, fines , Reprimand had notworked in the pastEmerging problems- Regulating internet pharmacy

INTERESTTo understudy the international best
regulatory practices as it pertains indeveloped and developing nations and adopt
them to Ghanaian situation.
This will strengthen our capacity tomodernise inspection and enforcement
activities at medicines distribution outlets toensure continuous improvement in accessto quality medicines .

－ 546 －

－ 547 －－ 549 －－ 550 －－ 551 －－ 552 －