㸫  㸫㸫  㸫㸫  㸫

TheScopeofPharmaceutical
AdministrationintheFederalDistrict,
BrazilMr.deOLIVEIRACARNEIRO,EmmanuelManagerofMedicinePurchasePlanning
PharmaceuticalAdministrationBureau

Agenda The Federal District, Brazil;
 Pharmaceutical Assistance in Brazil;
 Pharmaceutical Assistance in the Federal
District, Brazil.

㸫  㸫

TheFederalDistrict,Brazil
Area:5,779.999Km2
Population:2,914,830(2015)
Capital:Brasilia

15
Hospitals

7
Pharmacies

116PrimaryCareCenters

PharmaceuticalAssistanceinBrazil
 Brief history– Following the creation of Brazilian Unified Health
System, in 1990, the new National Medicines
Policy was designed to promote, regulate anddevelop several medicineͲrelated issues;– The reorientation of Pharmaceutical Assistancewas one of those issues.

㸫  㸫

ThePharmaceuticalAssistanceCycle
LicensingMarketentry/expansion

Selection

Surveillance
Therapeutic
followͲup

Dispensing

Planning

Maintenance

Acquisition

Distribution

Storage

PharmaceuticalAssistanceinBrazil The new proposed Pharmaceutical Assistanceis based on:– Decentralization of services;– Promotion of rational use of medicines;– Optimization of the cycleͲbased activities;

 Drug funding isgovernment levels.

supported㸫  㸫

by

the

3

OrganizationalChart
TheFederalDistrict
HealthDepartment
BrazilianHealth
SurveillanceAgency
MinistryofHealthStateHealthDepartment

MunicipalHealth
Department

OrganizationalChart
TheFederalDistrict
HealthDepartment

MinistryofHealth

Science,Technology
andStrategicHealth
ProductsSecretariat

HealthAssistance
Secretariat

Pharmaceutical
Administration
(Assistance)
BureauPharmaceutical
Administration(Assistance)
Bureau㸫  㸫

PharmaceuticalAssistanceinBrazil
 Major strengths– Visualizes most of pharmacy practice and includes
not just patientͲcentered practices, but drug
logistics also;– Decentralized services promote greater efficiency;– Service is universal and freeͲforͲall;– Its legislation is clear and concise regarding
aspects of pharmaceutical assistance.

PharmaceuticalAssistanceinBrazil
 Majorlimitations– Outside Brazil, the term “Pharmaceutical Assistance” is notwellͲknown;– In North America it refers to financial support of medicines(e.g., Medicare’s Pharmaceutical Assistance Program);– Public funding is threeͲtiered (federal, state, andmunicipal), unclear and inefficient;– Private funding is market/profit driven leading tocharacteristics of unnecessary drug use and prescriptionͲ
free drug access.

㸫  㸫

PharmaceuticalAssistance
intheFederalDistrict,Brazil Overview:– Shares State and Municipality Assignments– Drug selection is made by a Comission named“Pharmacy and Therapeutic Comission”:
 If a medicine is found costͲeffective and feasible forpurchasing, it is included in the “Standardized DrugList”;

PharmaceuticalAssistance
intheFederalDistrict,Brazil Overview:– Planning involves a budget impact analysis andestimation of drug utilization:
 Eligible number of patients and correspondent doses
are determined; The budget is projected for the current year;– Drug purchase is performed by Tendering Process
or Licitation;– Drug storage and distribution in a Central
Warehouse.

㸫  㸫

PharmaceuticalAssistance
intheFederalDistrict,Brazil
Dispensing of
medicines

Guidelinesfordrug
use

Coughs,colds,
tummyupset

Patient

Generalhealth
advicePharmacotherapeutic
followͲup

Prescriptionsreview

PharmaceuticalAssistance
intheFederalDistrict,Brazil

Challenges

㸫  㸫

PharmaceuticalAssistance
intheFederalDistrict,Brazil
Providecomputersandwebavailabilityinall
communityandhospitalpharmacies

PharmaceuticalAssistance
intheFederalDistrict,Brazil
Providesuitablestructureandfurniture㸫  㸫

PharmaceuticalAssistance
intheFederalDistrict,Brazil
CentralWarehouse:Present

PharmaceuticalAssistance
intheFederalDistrict,Brazil
CentralWarehouse:Future??

㸫  㸫

PharmaceuticalAssistance
intheFederalDistrict,Brazil
Budgetavailabilityfordrugpurchase~US$71,241,804.16

PharmaceuticalAssistance
intheFederalDistrict,Brazil

TargetCycle
Actions$

Universal
accessand
Rational
useofMedicines㸫  㸫

GGMON
GGFIS

GGPBS
GGMED

GELAS
GGGAF
GGCIP
GGPES
GGTIN

GGTAB

operacionalização de ações

GGTOX
sucom

sumed
GGREG

sutox

suges

GGTES

GGAIR

GGCOF
sureg

gestão tática

ssnvs

Geafe
aplan

GGInP

GGALI
aspar

suinp

corge
audit

ascom

GGcoe
GGiMv

GGCOS
suali

assessoramento transversal
GGTPS

AintE

secol
GGSAN

supaf
DIMON
gadip

DIARE

DIREG

procr

Orientação estratégica
asrel

DSNSV

DIGES

ouvid

DICOL
Conselho
consultivo㸫  㸫

Inception reportpresentation
Eduardo Agostinho Freitas Fernandes
MSc. Health Sciences
Regulation and Sanitary Surveillance Expert

LocationofAnvisa`s OfficeinBrazil㸫  㸫Brazilian Health Surveillance Agency(ANVISA)y Brief history
Ń 1998 – National Important Case of SSFFC product(Microvlar® - contraceptive)
Ń Jan/1999 - Creation of Brazilian Health Surveillance
Agency (ANVISA);Ń Fev/1999 – Establishment of Generic Medicines in Brazil.

Brazilian Health Surveillance Agency(ANVISA)

Organogram of ANVISA㸫  㸫

Inception report presentationy Coordination(CETER)of Therapeutic Equivalence

Conduct inspections on Bioequivalence Centers (GCP and
GLP)o Assess of bioequivalence studies
o Conduct inspection on Pharmaceutical Equivalence Centers(GLP)o Others: Reviewing regulations, etco㸫  㸫

Inception report presentationy Good PracticeoProblem: Problems with different information during theinspection and evaluation of the bioequivalence studiesoSolution: Transform the inspectors and assessors in only
one team.

Inception report presentationy Good PracticeooProblem: Competition for the submission
olution: Create codes in order to allow the submission to
be divided in pieces and to be delivered to the department
responsible㸫  㸫

Inception report presentationy Problem to tac
o
o

o

le

Problem: Lac of Comparator Product (Reference)easures ta en: n this case, we have assumed as the newcomparator the product with the most similar P profile But
as the new comparator doesn t show efficac and safet in
an clinical trials, can ou do it
Obs : e cannot choose an international comparator which is
not available in the Bra ilian mar et and from what we do not
have
aninformation
regardingclinicaltrialsandpharmacovigilance

Brasília - Brazil

October 1st, 2009

㸫  㸫II Congresso Internacional de
Medicamentos10㸫  㸫

Inception Report
DONG Wei-hua (CHINA)

Introduction of my hospital
The First Affiliated Hospital of
Xi’an JiaoTong University
a large comprehensive (first-rate ofLevel three) hospital in Xi’an,China
belonging to National Health andFamily Planning Commission of thePeople’s Republic of China
2497 beds
It occupies the leading position in
medical technology in thenorthwest of China
2㸫  㸫

Introduction of my work
I have been a pharmacist for 19 years
The job I have experienced:
drug purchasing
drug dispensing
drug quality control
TDM
clinical pharmacy

Now my job: pharmaceutical management

In China, Pharmacists is in the secondary position In hospital,
but the status of pharmacists is getting higher and higher.
3Good PracticeThe situation of the Pharmaceutical Department
in my hospital
more than 160 employees
6 divisions
outpatient pharmacy
inpatient pharmacy
traditional Chinese medicine pharmacy
drug warehouses
pharmacy intravenous admixture service (PIVAS)
clinical pharmacy4㸫  㸫Good Practice
The business of the pharmaceutical department
drug purchasing
drug dispensing
stock control
pharmacy intravenous admixture service
patient counselingtherapeutic drug monitoring
Clinical pharmacy
5Outpatient pharmacy hall

PIVAS

Automatic dispensing system

Single dose dispensing delivery system6㸫  㸫Drug storehouse

TDM instruments

Group photo of
Pharmaceutical
Department
7

Good Practice
My experiences about Good Practices
Past problems: There are emergency medicines reserved in wards.
Because they do not be often used, sometimes seldom of themwill exceed the validity period.
Methods: The pharmacists check all of the medicines in ward
every month. If invalid medicines are found, the duty nurse andhead-nurse will be punished by nursing department.
Achievements: Since then, the invalid medicines are almost neverseen in wards.
8㸫  㸫

Bad Practice
My experiences about bad Practices
Past problems: The prescription was filled and the patient took
away the medicines, but for some reasons, the patient asked toreturn some expensive oral medicine. The pharmacist can notaccept it because the medicine was unsafe.
Methods: We establish the rule䠖oral medicines can not be
returned.
Problems existing:Some patients do not obey the rule, they insist to return the
medicine.
Returned medicines are unsafe.
9

My interests

1. Are drugs sold in the pharmacy need to betested for the quality by the pharmaceutical
department?
2. How can we conduct research work andpublish papers in pharmacy department?
3. How to ensure the quality and safety of
intravenous admixture?
10㸫  㸫㸫  㸫

National Agency of Drug and FoodControl
Republic of Indonesia

Tokyo, November 2015

1

Category A
 Introduction of your work
- Organization & Department that you belongto- Job tenure- Please describe your regulatory services thatyou are engaged in㸫  㸫

VISION AND MISSION
Vision:Safe Food and Medicine to Improve Public Health and National
CompetitivenessMission:
1. Protecting public health by strengthening risk-based food anddrug control system
2. Ensuring the resilience of business operator to provide
medicine and food safety assurance, strengthening
partnerships with stakeholders
3. Improving institutional capacity of Badan POM

GOALS OF BADAN POM
2015 - 2019

1. Ensuring safety, efficacy, and qualityof food and drug to increase publichealth
2. Improving food and medicine
competitiveness nationally andglobally through quality assurance
and innovation.

㸫  㸫

STRATEGIC OBJECTIVES

1. Food and drug regulatory systemenhanced
2. The resilience of business operator andstakeholder partnership strengthened
3. Institutional capacity of Badan POM
improved

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

32 Regional Offices㸫  㸫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orate Of Drug And Biological Product
Organization of Directorate
Evaluation
Directorate
orate of Drug and Biol
Biological
Product Evaluation

Sub Directorate of
New Drug Evaluation

New Drug Evaluation
Section Path I & III

New Drug Evaluation Section
Path II

Sub Directorate ofSu
Copy Drug and Biological
Product Evaluation
Pro
Pr

Copy Drug Evaluation
SectionDrug Reevaluation SectionD

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

Therapeutic Productfor Special Access Scheme
SectionBiological ProductEvaluation Section
Administration andOperational Section
7

Drug Regulatory System
in Indonesia㸫  㸫REGULATORY FRAMEWORKON ENSURING S, E, Q
OF MEDICINE
Medicine Quality Assurance Structural
Components
Assured Medicine S, E, Q
Documentation, Monitoring
Documentation
Monitoring, and Evaluation
Pre Market
Assessment(marketauthorization/
licensing andregistration)

Regulatory
Elements(full spectrum/
comprehensivefunctions including
inspection, recall,central & provincial
labs)

Technical
Elements(quality
specifications,basic tests, GLP,
GMP, GCP, GSP,
GDP, GPP)

Post Market
authorization
surveillance(for quality andadverse events,
and productinformation/
promotion)

Prevention and law enforcement

MEDICINE CONTROL SYSTEM IN INDONESIA

Consumers

PUBLIC HEALTH
PROTECTION

Government

 Substandard
product : safety,
effectiveness,quality Access to
medicine Abused &misusedmedicine,
narcotic,
psychotropic

Pharm
Industries /Wholesalers㸫  㸫

CRITERIA FOR MEDICINE EVALUATION
Efficacy and
SafetyQualityͻ cGMPͻ Specificationaccording toPharmacopeia

ͻ Pre-clinical

trialsͻ Clinical trials(phase I, II
and III)

According to theactual need ofthe population

Labellingͻ Truthfulͻ Not misleadingͻ Complete

Specific criteria:- Psychotropic
superior for S & E- Contraception andMedicine for
HealthHeal Programme

Need Assessment

Risk Based Review

FDA

Registration
system inothercountries

MEB

National Committee
on Drug Evaluation

EVALUATOR

Other
NRA

Registration
system inothercountries

Other
NRA

AFSSAP

CORE OF REGULATORY FUNCTION
Pre-Market

Post-Market

 Review and approval of
medicinal products for clinical
trials Æ 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 Æ 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㸫  㸫The Role of NADFC on Drug Registration

5HJXODWLRQRIWKH0LQLVWHURI+HDOWK
1R0(1.(63(5;,RQ'UXJ5HJLVWUDWLRQ'HFUHHRI+HDGRI1$')&1R+.
 RQ&ULWHULDDQG3URFHGXUHRI'UXJ5HJLVWUDWLRQ

7KHUDSHXWLFSURGXFW WREHPDUNHWHG
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WKURXJKUHJLVWUDWLRQSURFHVVLQ1$')&SULRUWR0DUNHWLQJ$XWKRUL]DWLRQ

WHO SHOULD
APPLY?

Pharmaceutical Industries
Located in Indonesia ÎMAHHow to apply
registration
stration 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
14㸫  㸫REGISTRATION CATEGORYNEW REGISTRATIONVARIATION

RENEWAL
Category 7

Category 1
New Drug and Biological
Products, including Similar
Biotherapeutic Product (SBP)

Category 4
Major Variation(VaMa)

Category 5

Category 2
Copy Drug/Generics

Category 3

Minor variation with approval(VaMi-B)

Category 6

Other product that contain
pharmaceutical substance(eg.
IUD)

Minor variation with notification(VaMi-A)
15

TIMELINES for EVALUATION
40 WD

ͻ Minor variation which need approvalͻ Application for Export only

100 WDͻ Life saving drugs
ͻ Orphan drugs
ͻ Drugs for National Programͻ Drug development and all Clinical Trials conducted in Indonesiaͻ Copy Drugs with Electronic Standardized Information
ͻ Major Variation i.e New Indication/posology for live saving drug, orphan drug,
drug for National Program , drug which developed and clinical trials in Indonesia

150 WDͻ Drug which has been marketed in the countries which have implemented harmonizedevaluation system.
ͻ Major Variation (New Indication/posology) which has been marketed in the countries whichhave implemented harmonized evaluation system.
ͻ Copy drug without Electronic Standardized Information

300 WD

ͻ New drugs, Biological Products, Similar Biotherapeutic Products, Major Variation (Newindication / posology) which are not included in path 100 WD and 150 WD

16㸫  㸫

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
17

Validity of Marketing
Authorization

5
Years

18

㸫  㸫

Category B—Good Practice- Please describe your experiences about goodpractices
Examplesa. Achievements
b. Solutions for past problemsc. On-going projects to deal with current problems
d. Successful countermeasures against problems

PRE MARKET CONTROLDRUGEVALUATION/REGISTRATION㸫  㸫Concept of Pre-Market Evaluation
CRITERIA AND REQUIREMENTS

Scientifically SoundGOOD
DOSSIER
PRACTICES

Within timetargetLegally &scientificallyconsistent

Procedurally
predictable

1. Good, clear & definedprocess
2. Consistent application

GOOD
DOSSIER
PRACTICES

3. Well trained people
4. Good Management
Review Practices

Good Quality Decision

PRODUCTS WITH REGISTRATION NUMBER

21

DRUG REGISTRATION AND EVALUATION FLOWCHART
Ya
ComplyKeterangan
National Committee on Drug Evaluation

Tidak

Consultatio

Pre Registration

Applicant

New Drug and
Biological
Product:

Evaluation on Quality
Ȉ Active substanceȈ Source
Ȉ The synthesis processȈ Specification
Ȉ Analytical method
Ȉ Stability
Ȉ Product (Drug)Ȉ Composition
Ȉ Specification
Ȉ Validation of analyticalmethods
Ȉ Process Validation
Ȉ Analytical methods
Ȉ Stability

Lengkap
Obat Copy:Ȉ Jalur 100 HK
Ȉ Jalur 150 HK

Additional data

AppealSMF data forimport drug *)Preinspection
document
evaluation

Rejection/Appeal
Additional Data

- Abreviated Safety and efficacy
data- Bioequivalence

Article 31

Data
Completeness Assessment

SMF Evaluation

In SituȈ 100 WDȈ 150 WDȈ 300 WD

Incomplete

Registration

Evaluation on safety and efficacy-Nnon clinical- Pharmacodynamic- Pharmacokinetics- Toxicity- immunogenicity- Clinical- Phase I, II, III- Phase IV (optional)

Pre
Registration
ResultDrugregistration

Pre Registration

Complyly?

Comply?

Yes

No

Labellingevaluation

AL

MA
Additional
Data

Rejected

Ya

Inspection

Ya

Tidak
No

㸫  㸫*) Pharmaceutical Industry should be
inspected

What is Generic Drug?
Drugs contain active pharmaceutical ingredientsthat have the same :- composition/quantity- stregth- dosage form
- route of administration- indication- posology
as the originator
23

Production Status Local Product– Produced by marketing authorization holder– Toll manufactured product– License product Import Product24

㸫  㸫

Generic DossierPart I
Administrative
Document

Part II
Quality
Document

ͻAdministrative Data
ͻProduct Information

ͻDrug SubstanceͻDrug Product25

Administrative Document
 $GPLQLVWUDWLYHGDWD
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/DWHVW6LWH0DVWHU)LOHIRURYHUVHDVSKDUPDFHXWLFDOLQGXVWU\WKDWKDVQRWKDGDSURGXFWZLWKWKHVDPHW\SHDQGGRVDJHIRUPVWKDWDSSURYHGWREHPDUNHWHGLQ,QGRQHVLD

y 3URGXFW,QIRUPDWLRQ
Æ ODEHOOLQJDQGVXPPDU\SURGXFWFKDUDFWHULVWLF
EURFKXUHOHDIOHW
26

㸫  㸫

Quality Document
QUALITY OVERALL SUMMARY
S. DRUG SUBSTANCE
NCE
ͻ S.1. General information (Nomenclature,
Structural formula, General properties)
ͻ S. 2 Manufacturing process andManufacturer(s) (manufacturer, description of
manufacturing process and process control,
control of material, controls of critical steps andintermediates)ͻ S.3 Characterisation
ͻ S. 4 Control of drug substances : specification &analytical procedures include validation ofanalytical procedures, batch analyses, andjustification of specification
ͻ S. 5 Reference standards or material
ͻ S.6 Container closure system
ͻ S.7 Stability

P. DRUGP
DRU PRODUCTͻ P.1. Description and composition
ͻ P.2.Pharmaceutical development
ͻ Information on development studies
ͻ Component of drug productͻ Finished productͻ Manufacturing process development
ͻ Container closure system
ͻ Microbiological attributes
ͻ Compatibility
ͻ P.3 Manufactureͻ Batch formulaͻ Manufacturing process and process control
ͻ Controls of critical steps and intermediates
ͻ Process validation and/or evaluation
ͻ P. 4 Control excipients : specification and analyticalprocedures, result of internal test
ͻ P.5 Control of finished product : specification, analyticalprocedures, validation of analytical procedures, batch
analyses, characterization of impurities, justification of
specification
ͻ P. 6 Reference standards or materials
ͻ P.7 Container closure system
ͻ P8. Stability
ͻ P.9 Equivalence evidence27

Current situation in Indonesia
 About 96% of APIs are imported
 About 90% of drug substances are imported
Top 5 source of API:
 China India Korea Japan Europe28㸫  㸫

Quality Requirement
Active Pharmaceutical Ingredient Master
File (APIMF) requirement data :1. A Valid quality Certificate of Suitability of European Pharmacopeia(CEP) With all appendices Provide information, which may not be covered by the CEPor
2. An API MF (API Master File) Submitted by API manufacturer
 Contains all information requested in section 2.S. Drug
substance
5HTXLUHPHQWIRUVW *HQHULFVWDUWHG
LQRQYROXQWDU\EDVLV
29

Quality Requirement
On site evaluation at the facility of
product manufacture (in-situ)To support the quality of products
For mapping the suitability of the quality of datasubmitted in the dossier with the documentationin the production of medicines in facility.
To ensure the validity of information written in
documents of Quality as well as to check the30
GMP inspection㸫  㸫Good Manufacturing PracticeInspection

GMP
CERTIFICATION

x 0DQXIDFWXUHUVKRXOGFRQILUPZLWK*03UHTXLUHPHQWV
x *03&HUWLILFDWHZLOOEHJLYHQLIWKHUHTXLUHPHQWVLV
FRQILUPHG
x *03&HUWLILFDWHLVLVVXHGIRUHDFKGRVDJHIRUP

Relationship Between Dynamic GMP andRegistration Requirements

Dynamic GMP (cGMP)

Registration Requirement

Raw Material

Product Development: Pre-formulation,
Design Process,Validation, Stability
Test

GMP Data

Dossier

Efficacy
Safety &Quality Data

Specification, Analytical Method,
Comparable raw material

Premises
Administr
ation Data

Production Facility, Qualificationof Equipment, Personnel Training

Validation

Product Evaluation

 Analytical Method
 ProcessMarketing Authorization㸫  㸫

Category C---Bad Practice- Please describe your experiences about Badpractices
Examplesa. Problems that cannot be improved or haven’t
been improvedb. Failed countermeasures to deal with past
problemsc. Emerging problems because past problems
haven’t been solved

1. Challenges in the implementation part includes among other
different interpretation from the perspective of the government andthe stakeholders by many functions and hierarchies. Regulatory
improvement is needed for more effective and efficient
implementation to support pharmaceutical trade.
2. Obstacles in regulating medicines and medical devices to facilitate
trade are among other :i. Different level of maturity in understanding and implementing theregulation and guidance amongst the industries and the regulator
staffsii. Inefficiency in implementing the regulation and guidelinesiii. Limited resources, for example, well trained staffs and needimproved IT, infrastructure and capability㸫  㸫MARKETING AUTHORIZATION FOR MEDICINE & CLINICAL TRIAL
FINDINGS
1.

2.
3.

DISCUSSION

Guideline for MA & Technicalrequirements are available, based on
WHO & International Standard
MA Dossier & Requirements follow
ASEAN formats (ACTD &ACTR)
Transfer of Technology requirements
is included in the Regulation on MA(imported products)

The Guideline needs to besupported with clear technicaldirective, e,g Questions andAnswer documents
No publicly written procedureon special cases commonly
faced with the application &how the evaluation being done
MA decision process should
be more publicly transparant,
including hearing & appeal

1.

2.

3.

PRODUCTION/MANUFACTURING PROCESS CONTROLFINDINGS
1.

2.
3.

4.

DISCUSSION

Regulation & Guidance for cGMP areavailable to ensure that product areconsistently manufactured to meet
specified Q approppriate to their intended
use.
Indonesia is the 41st PIC/s member
The GMP based on PIC/S and other
International Std will provide protection
from defects products & recall so thatsustainability of availability product ofassured QSE is ensured
Adoption of new regulatory practices or
new technology may affect product priceat the begining, but if it is done efficiently,
it could lead to more affordable product㸫  㸫

1.

2.

3.

Implementation of cGMP
needs technical directive, inparticular for transfer oftechnology
Additional investment may beneeded in order to reach &increase the bar of product
QC / standard, & the
manufacturer capability need
to be strengthen as well.
Government’s support isneeded e.g, GMP inspection
being consistently done,
availability of raw material ,strategy on centralizing
production, insentive scheme
for transfer of technology etc

TRANSFER OF TECHNOLOGY ON PHARMACEUTICALSFINDINGS
1.

2.

DISCUSSIONS

To support local capacity of 1.
manufacturing, Transfer ofTechnology is stated inregulation related to MA
and GMP (imported
products)
2.
Transfer of Technology
covers (i) productdevelopment, (ii) technicaland method or process of
production and (iii) Quality
Assurance

Critical issue of Transfer ofTechnology is economics ofscale for new investment,
effort for R&D, stringent
regulatory requirement.
Incentive scheme isneeded, e.g regulation &technical GL to speed up
the process, facilitation for
funding/loan facility,
deffered import tax for
capital goods, etc

Category DYour interests- Please describe topics you look forward to most in thisprogram (at maximum three topics) Better understanding of regulatory management foraccess to quality-assured medicines including
inspection system, as well as trends of international
collaboration among regulatory authorities
 Critical issue of Transfer of Technology
 Counterfeit medicine’s distribution and the problems
related which may lead to public health issue.

㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫

"Roles of Regulatory Systems and Pharmacists on
Ensuring Proper Access to Quality Assured Medicines"

Country Presentation: Papua New Guinea
Graham Wavimbukie
Quality Control Unit
Pharmaceutical Services Branch
National Department of Health

Introduction
Pop:7.5mill
Language:700plus,Official,EnglishandPidgin㸫  㸫

Introduction– (Maplocation)

IntroductionͲ Organization
Introduction
Organization–

NationalDepartmentofHealth
MedicalStandardsDivision
PharmaceuticalServicesBranch
QualityControlUnit

Branch–9wascreatedrecentlyin2011afterrecommendationbyAusAID in2008
Weareworkingtodevelop,improveandaligndrugregulatorysystems

Jobtenure–Ͳ PharmacistbyProfession
Ͳ TechnicalAdvisor– QualityControlͲ 4yearsofservicenow,joinedin2011

9

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

㸫  㸫

OrganizationalStructure– MinistryofHealth
OfficeoftheMinister

OfficeoftheSecretary

PolicyandCorporateService

HealthServiceStandards

CorporateServices

StrategicPolicy(EM)MedicalSuppliesProcurement

Procurement

MedicalStores&Distribution

Pharmaceutical
Care

MedicalStandards

Public HealthPharmaceuticalStandards

TB/HIV/Malaria/FamilyHealthCompliance&
Inspection

Product
Registration

GoodPractices
GoodPractices
9

Experiences/Examples
GoodStoragePractices(GSP),GoodDistributionPractices(GDP)andGoodPharmacyPractice(GPP)Ͳ WHOStandard

AchievementsͲ CreationandDesignationofPharmaceuticalRegulatoryBranchin2010
Ͳ JointheWHOUpsalla forADRreportingandmonitoring2013
Ͳ RevisionoftheMedicinesPolicyandpassedbyGov;t 2014
Ͳ Appointmentandgazettalfor24Inspectorsnationwide2013

Solutionsforpastproblems

Ͳ

Ͳ
Ͳ
Ͳ
Ͳ

SourcingofmedicinesandvaccinesfromWHOprequalifiedmanufacturers
QualityTestinginWHOaccreditedlabs
Increasedinspectionsmostlyspotandsiteinspections㸫  㸫QualitycontrolGoodPractices(2)
Ongoingprojectstodealwithcurrentproblems
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ

Improvedrugregistrationprocessandguidelinesforcommencementofregistration
ConstructionofaQualityControlLaboratory
RollofoutHospitalBasedTherapeuticCommittees
RevisionofActandRegulations
RevisionofMOUwithTGAAustralia,andhopefullyestablishnewwithMalaysia

Badpractices
9999LackofNetworkingandinternationalcooperation
NoGMPclearanceforoverseasmanufacturers
NoRegulationofpriceformedicines
VerylittlepostmarketsurveillanceWayforward
Learnandadoptgoodpracticesfromothereconomies

AreasofInterest
Interests(3areasfromthiscourse)
9MarketApproval(generics)
9
CountermeasuresagainstCounterfeitsandSSFFCmedicines9GMP㸫  㸫

InceptionReportPresentation

ReubenO.Kigil
Pharmacist&PharmaceuticalInspector
MilneBayProvincialHealthAuthority
PapuaNewGuinea
1

Outline Introduction
 GoodPractice BadPractice MyInterests2㸫  㸫

Introduction
 MilneBayProvinceofPapuaNewGuineaData– Maritimeprovince&theeasterntipofPNG– Pop.: 276,000(2011),Averageage:55Ͳ60yrs
– Growthrate:
2.5% (4child/woman)– ProvincialHospital: 01– DistrictHospitals: 02(1Pharm.Technician)– HealthCentres:
37– Aidposts(open): 108– Prov.Dispenser:
01(1Pharm.Technician)3

Introcont’d Prov.Hospitalfacts– 177beds– 4mainclinicaldept.
– 524(726– MBPHA)– 3Pharmacists(1Clinical
andManager,1Pharm.
Inspector)– 1 PharmacyTechnician– 1ProcurementOfficer– 1Storeman– 4.3metressq.disp.
room– 149Outpatients/day4㸫  㸫

Introcont’d Pharmacist– Dispensemedicinestooutpatients&inpatients,– Attendtowardordersbasedonimprestsystem,– Maintainstockinventory,– SubmitorderstoAreaMedicalStorefornewstock,– DoquarterlytripstoAreaMedicalStoretofast
trackorders,– Goonsupervisorypatrolstoruralareas

5

Introcont’d PharmaceuticalInspector– Inspectshopsandinformalmarketsforillegalsalesofmedicines,– Inspectretailpharmaciesannuallyforcompliancetostandardsbeforerenewaloflicense,– InspectpublichealthfacilitiesforcompliancetoGoodStoragePracticesandstandards,– Dopublicawareness's.

6㸫  㸫

7

Introcont’d Pharmacistsmainroleinmycountryat
presentismanagementofmedicalsuppliesat
differentlevelsofallhealthfacilities.Itstarts
fromprocurement,storage,distributionto
healthfacilitiesandeventuallydispensingto
patients.Qualityofthemedicalsuppliesare
checked(physicalobservations)atalllevels.

8㸫  㸫GoodPractices
 Achievements&Solutionstopastproblems– ImprestSystemͲ (2003)– ShelvesandworkbenchesinstallationͲ 2006
– NewpatientwaitingareaͲ 2012
– Averagemonthlyconsumption(AMC)Ͳ 2014
– Inventorysystem(StockcardstomSupply– 9/2015)– Prepacksfordispensing– Weeklyvisitstowardstocheckimprestcupboards– QuarterlytripstoAreaMedicalStores(x5)9GoodPracticescont’d Ongoingprojectstodealwithcurrent
problems.Maintain:– dataentryintomSupply– prepackingfordispensingtooutpatients– stocktakes– quarterlytripstoAMS– SubmitAMCtoNationalDept.ofHealth

10㸫  㸫GoodPracticescont’d Successfulcountermeasuresagainstproblems– MaintainingdataentryintomSupply

11

BadPractices
 Stealing¾ Onthreeseparateoccasions– x3staffssacked

 Warehouseisstillinamess Requestsforpalletswerenotentertained Sendingstoremanalonetowarehouse Shelvingstillamess NoTDM/MTC NoClinicalWardrounds
 Stocktakeisstillonaadhocbasis FrequentordersfromHCtoHospital12㸫  㸫MyInterests
 PharmaceuticalregulatorysysteminJapan
(Legislation,Pharmaceuticalapprovalsystem,GoodManufacturingPractices(GMP),Health
insurancesystemanddrugpricelisting,Safety
measures. RoleofstakeholderstoensurequalityͲassured
medicines(Activitiesbyimporters,
manufacturingcompanies,wholesalers,
hospitalsandpharmacies).
13

 Anata nochui oarigatogozaimashita!
 Shitsumon ya komento wa?

14㸫  㸫㸫  㸫 
  ȋ ͳͷǦͲͶ͵ͺ͸Ȍ Ȃ 

Yadalgoda Muhandiramlage Priyantha KUMARA
StatePharmaceuticalsManufacturingCorporation– SriLankawww.spmclanka.lk

WhatisSPMC– SriLanka
 State Pharmaceuticals Manufacturing Corporation is thesole state sector manufacturer of pharmaceuticals to
the Sri Lankan nation.
 SPMC is established under Industrial Corporation Act
number 49 in 1987
 Donation from Japanese government and JICA in 1987
 We have a product list about 69 drugs which fulfill apart of essential drugs in Sri Lanka.
 Our annual capacity now exceeds 2000 million tabletsand capsules.
 In 2016 another expansion program stats with the aidof Japanese Government to increase the out put to4000 million units.
㸫  㸫

CategoryA
Introductionofwork
1.Manufacturingofproducts

Production department is responsible inmanufacturing of tablets and capsules in SPMC.
Therefore our key objective is to carry out all theprocesses up to the standards stated in thepharmacopoeias without any quality defect. To
obtain the quality level we try our best to follow
the Standard Operating Procedures, implement
and follow GMP regulations.

2.Validationofmanufacturingprocess
Our ultimate goal is to manufacture aquality product. With that aim the production
department together with the formulationand quality control departments involve invalidation of the manufacturing processes oftablets and capsules.

㸫  㸫

3.Maintainingproductiondataand
cleaningdataastocomplywithGMP.
 All the documents maintained for 5 years until
the products exceeds its shelf life.
 If some marketing complain occurs in themarket we should be able to trace the file.
 When NMRA(National Medicines Regulatory
Authority) inspect the premises for reͲ
registration we should be able to produce
required data.

4.Conductingtraininganddevelopmentof
traineesanduniversitystudents SPMCrecruitsnewpeopleforproductionandqualitycontrol
departmentsfromAdvancelevelsciencestream.Sowehavetotrainthemforthejobatleastoneandhalfyears.There
theycanawareabouteverydepartmentinSPMClike
Production,QualityControl,Maintenance,Procurement,Marketing,FinanceandAdministration.
 SriLankanowconductingB.Sc (Pharmacy)andB.Pharm
degreesinNationalUniversities.Soweareprovidingthemthe
industrialvisitsandrelevanttrainingasneeded.Otherthan
thatiftheyneedanytechnicalassistancefortheirprojectswegiveoursupport.

㸫  㸫

CategoryBͲ Goodpractices
1.Qualitycheckingofrawmaterialsat4intervals
 Atthetendersampling–initialtender
samplesarechecked PreͲshipmentsamplingͲ samplesfromtheexactlythesamebatchestobesent.
 FullanalysisTestingͲonesamplefromeachbatch IdentificationtestͲtestingofeachdrum

Contd..
2.InͲprocessqualitychecking
 Tablet weights are statistically controlledduring manufacturing to ensure the dose of
the tablets.
 Weights of tablets are monitored bynarrowing down the pharmacopeia standards
3.Finishedgoodqualitychecking
 Finished goods are checked before releasing
the products to the market.
4.AdheretoGMPguidelinesinManufacturing.
5.FollowBritishPharmacopoeia,UnitedStates
Pharmacopoeiastandardsformanufacturingandqualitycontrol.
㸫  㸫

CategoryCͲ BADPRACTICES
1. Procuring of raw materials by not selecting
suppliers but through Government Tender
Procedures.
ͲProcess validation is not convenient.
2. Selecting suppliers through questionnaires
without visiting the suppliers.
ͲSupplier reliability is questionable

3. Do not have mechanism to do GMP audit toknow at what level we adhere to GMP.
4. No post marketing surveillance. So lack of data
after marketing the product and do not havemechanism to do competitive analysis.

CategoryD
INTERESTTROPICS
1. GMP auditsͲ
one of my primary interests is to learn how
to carry out a GMP audit. As a manufacturing firm
we are directly involved in implementing andfollowing GMP regulations within the factory
premises. If we have a fair knowledge about GMP
auditing that would be an added advantage for us
to correct our shortcomings. Also this would
upgrade the level of standards in our organization.

㸫  㸫

2. Health insurance system proceed in japanͲͲHow the health insurance system proceed in Japanaccording to the government regulations.

3. How to carry out of clinical trials of the drugs
and bio equivalence testing.
4. ADR reporting system and Product recall
proceduresͲͲ It is mandatory to establish a correct recall procedure.

5.RegulationsinHerbalmedicineinJapanͲͲHowtheherbaldrugsareregulatedandthe
conditionsforstoringherbalproducts.

㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫㸫  㸫

“The National Medicines and Poisons Board

Roles of RegulatorySystems and Pharmacists on
Ensuring Proper Access to Quality Assured Medicines

Sudan’s Experience Of Medicines
Regulation”

Dr. Ahmed Yagoub Yahia Dafaalla
Inspector of pharmaceuticals manufacturer of Sudan’s NRA
November 2015

Who is the National Medicines and PoisonsBoard (NMPB) ?

The BOARD is authorizedi ed bbody for the setting &development of regulation in Sudan, it also responsibleof quality assurance measures to ensure the safety,
effectiveness and quality of pharmaceutical products,
medical devices and cosmetics, as needed, in order toprotect and promote the health and wellbeing of thepeoples.

㸫  㸫

Vision The BOARD aspires to develop and take sound andeffective regulation and quality assurance measures toensure the safety, effectiveness and quality ofpharmaceutical products, medical devices and cosmetics,
as needed, in order to protect and promote the health andwellbeing of the Sudanese people and to attain the strategic
goals set by the state; using scientific approaches based on the principles of good
governance and values of justice, transparency andpartnership.

Mission The BOARD is committed to ensure the safety, efficacy
and quality of pharmaceutical products, medical devices
and cosmetics by instituting and maintaining acompetent and effective national regulatory system,
structures and resources capable of providing thenecessary regulatory services and achieving the national
objectives of the BOARD.

㸫  㸫

Update Of Laws

In 2007;
Act – 2001: Reform of
formulation the board;
becomingof theindependent
Act 1963:
National
body
Establishme Board for1939 The
chaired by
nt Of
Pharmacy
Poisons
Pharmacyand Poisons the Federal
Regulations
Minister ofDepartment
HealthWithin The
FMOH,

Act 2009:
update of theact to add
the missed
elements

Legal Framework For Medicines Regulations

Board

State authority

Act 2009
GeneralSecretariat

Committees andexternal expertise
GS departments






Quality Management System
Funding
Governance
HR: independent recruitment㸫  㸫6

Organizational Structure And Functional
Secretariat

Secretary General

Directorate
ct
GeneralneofPlanning

Directorate
General of
Medicine
control

Directorate
General ofRegistratio
gistra
n

NQCL

Human
resources
esourcesandfinancing

The Aim of the Secretariat General Quality assurance of medicines in the Sudanese market
and prevention of entry of counterfeit, substandard andlow quality medicines, by establishing a secretariat
effectively and powerfully operate according to theappropriate laws.

㸫  㸫The main objectives of the Secretariat
General: Assurance of safety and quality of human and veterinary
medicines.
 Setting standards for medical and diagnostics devices.
 Control and supervision of the special procedures for licensing
pharmaceutical and medical devices plants.
 Exchange and dissemination of information with legal andscientific organizations both locally and internationally andpreparation of medicine data base.

The BOARD is carrying out their duties
through well trained technical staff &professional committees.

㸫  㸫

Technical Committees

 Registration committee of:¾ Human medicines.
¾ Vet medicines.
¾ Medical Devices.
¾ Cosmetics.
¾ Herbal Medicines.
 Licensing Committee.
 Appeal Committee.
 Ethical Committee.
 Legislation Committee.
 Costing & Pricing.

National Drug Quality Control Laboratory
 Conducting the required laboratory tests for samples ofpharmaceutical preparations, starting materials, biologicalproducts and cosmetics. The analysis could be pre and/or post
marketing.
 Participation in setting specifications and standards for drugs andmedicinal preparation for public sector tenders.
 Participation in GMP (Good Manufacturing Practice) and GLP(Good Laboratory Practice) inspection for both local and foreign
pharmaceutical firms.
 Participation in medicines and pharmaceutical preparation
inspection at the borders and also in warehoused goods forgeneral sale.
 Conducting studies and research to develop method of analysis
and to establish comparative bioequivalence testing procedures.

㸫  㸫

Directorate General of Medicines
Registration
I.

Human Medicines Registration Directorate

II. Veterinary Medicines Registration Directorate
III. Medical Devices Assessment Directorate
IV. Cosmetics Registration Directorate

I. Human Medicines Registration
Directorate

The main job is assessment and evaluation ofregistration application of human medicine which
may be; chemical, herbal, biotechnology, hormonesand vaccines preparation.
Also it works as a secretariat for Human Medicine
Registration Committee.

㸫  㸫II. Veterinary Medicines Registration
DirectorateIt is responsible for the evaluation of registration
applications of veterinary medicines including
those preparations which are used to increasing
animal weight by an anabolic effect or the
production of animal products such as milk.
Also it acts as the secretariat for Veterinary
Medicine Registration Committee.

III. Medical Devices DirectorateResponsible for the assurance of safety andefficacy of all medical devices from simple wounddressing to complex diagnostics machines.
Works as a secretariat for Medical Devices
Registration Committee.

㸫  㸫IV. Cosmetics Registration
DirectorateResponsible for the assurance of quality and safetyof cosmetics preparation
It works as secretariat for Cosmetics Registration
Committee.

Directorate General of
Medicines ControlI.

GMP Compliance Department

II. GDP Inspections Department
III. Importation Department
IV. PMS Department㸫  㸫

Directorate General of Medicines
Control Responsible for the quality assurance of imported
medicines and it monitors quality and safety throughout
storage and distribution. The main duties are:
 Prevention of the importation of unregistered medicines.
 To ensure that appropriate action is taken when receiving
reports of low quality medicine.
 Investigation of manufacturing, importation, sale, supplyof any suspicious illegal drugs, cosmetics or medical
devices.

Directorate General of Medicines
ControlPost marketing surveillance.
Monitoring adverse drug reactions
Inspection of local & foreign facilities.
Costing & Pricing of medicines.
 Control narcotics & Psycotropic medicines㸫  㸫

Stakeholders

Governmental Sector:- CMS.
- Customs.
- Police- etc.

¾ Non- Governmental Sector:- Importers.
- Manufacturers.
- Civil Societies/NGOs.
- etc.

Achievements and best experiences inmedicines regulation¾ Implementation of electronic system for clearance of imported
medicines, in collaboration with concerned authorities¾ Formulationofsettlement

policyfor

local

pharmaceuticalmanufacture, as part of the investment encouragement policy¾ Organization of the first conference for medicines regulatory
authorities in Sudan and neighboring countries, in collaboration withWHO during December 2014
¾ Cooperation for effective regulation of medicines㸫  㸫

Promoting partnership towards effective
harmonization of medicines regulations¾ The Conference Recommends: to start projects withIGAD and other neighboring countries on cross-border
supplychain

security

andcombating

Substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC) medical productsby sharing reporting on (SSFFC) medical products

Challenges In Medicine Regulation¾ Inadequate functionality of regulatory authorities at thestates level and weak connection though LIMS System.
¾ Introduction of CTD and bioequivalence studies¾ Vast open borders with 7 countries¾ Achievement of collaboration and harmonization atregional and international levels㸫  㸫

Challenges In Medicine
Regulations¾ Retention of highly skilled personnel¾ Financial policies/systems¾ Relation with private sector to enforce regulations¾ Regulations of medical devices- new experience

Challenges In Medicine Regulations
Increasing capacity of NQCL:- Equipments- Supplies- Rehabilitation- International Standards (Prequalification, etc)
 Increasing capacity of Medicines control.
- PIC/S members- Prequalification of Inspectors
Human resources- Training- Motivations
Limited financial resources㸫  㸫

Opportunities In Medicine Regulation¾ High political commitment¾ Technical independency - strong decisions¾ Willingness

forcollaboration

among

partners

includingneighboring countries¾ Promising pharmaceutical market in East Africa and IGAD
countries¾ Existing successful stories for capacity building (pre-qualified
laboratories, CTD,…etc)

Way Forward¾ We confirm that Sudan is looking forward to beeffective partner and to do our best in order toimplement the outcomes of this this training knowledge
and experience.

㸫  㸫29

30

㸫  㸫