Silviase/jgov_v1.4_full_ann huggingface dataset:
Source: "National Health and Nutrition Survey Japan, 2009", Health Service Bureau, MHLW

Detailed Data 8 Status with Smoking Rate

Source: “National Nutrition Survey” up to 2002 and “National Health and Nutrition Survey Japan” from 2003 onward

(Note) Definition of smoking and survey methods differ between the National Nutrition Survey and the National Health and Nutrition Survey Japan hence figures cannot simply be compared.

Smoking rate in foreign countries (\%)

Country	Males	Females
Japan	(36.8)	(9.1)
38.2	10.9
Germany	(37.3)	(28.0)
34.8	27.3
France	(30.0)	(21.2)
33.3	26.5
Netherlands	(35.8)	(28.4)
31.0	25.0
Italy	(31.3)	(17.2)
28.3	16.2
U.K.	(27.0)	(25.0)
22.0	20.0
Canada	(22.0)	(17.0)
19.9	15.5
U.S.A.	(24.1)	(19.2)
23.9	18.0
Australia	(18.6)	(16.3)
16.6	15.2
Sweden	(16.7)	(18.3)
16.5	18.8

Source: WHO Tobacco ATLAS (2009)

“National Health and Nutrition Survey Japan, 2009” for the figures for Japan

(Note) The figures in parentheses are from WHO Tobacco ATLAS (2006) and the National Health and Nutrition Survey Japan, 2008
Overview 8020 (Eighty-Twenty) Campaign

[History of 8020 (Eighty-Twenty) Campaign]

1989	A Study Group on the Dental Health Policy for Adults made public its interim report in which the "8020 (Eighty-Twenty) Campaign" calling for the retention of 20 or more teeth even at age 80 was proposed.
1991	"Promotion of 8020 Campaign" was set to be the major objective for the Dental Hygiene Week (June 4-10).
1992	"8020 Campaign promotion measure projects" launched for dissemination and enlightenment of the 8020 Campaign (until 1996).
1993	8020 Campaign promotion support projects launched for smooth implementation of 8020 Campaign promotion measure projects (until 1997).
1996	Study Group on the Future Dental Health and Medical Care pointed out in its written opinion that pointed out that the 8020 Campaign should be developed in a more practical and community-oriented manner.
1997	Municipal dental health promotion projects (menu projects) launched.
2000	Prefecture-led "8020 Campaign promotion special projects" launched.
2003	Dental health support model projects for operators of health promotion projects launched.
2006	The results of the "Survey of Dental Diseases (2005)" was published to reveal that the percentage of persons achieving 8020 reached over 20% for the first time since the survey started.
2008	8020 Campaign marked the 20th anniversary.
2011	The Act on Advancement of Dental and Oral Health was approved.

## [Relationship between 8020 Campaign and Health Japan 21]

The “8020 Campaign” and “Health Japan 21” are complementary to each other and the projects to accomplish the goals of Health Japan 21 have been implemented within the framework of the 8020 Campaign. As dental health was explicitly stated as a key point in the Health Promotion Act, further promotion of lifelong dental health projects (8020 Campaign) is expected.

Changes in Percentage of Persons Having 20 or More Teeth by Age Group

Age Year	40-44	45-49	50-54	55-59	60-64	65-69	70-74	75-79	80-85	85+
1993	92.9%	88.1%	77.9%	67.5%	40.9%	31.4%	25.5%	10.0%	11.7%	5.6%
1999	97.1%	90.0%	84.3%	74.6%	64.9%	48.8%	31.9%	17.5%	13.0%	3.0%
2005	98.0%	95.0%	88.9%	82.3%	70.3%	57.1%	42.3%	27.1%	21.1%	8.3%

Source: “Survey of Dental Diseases”, Health Policy Bureau, MHLW
## Overview

## Future Direction with the “3rd-Term Comprehensive 10-year Cancer Control Strategy”

Goal of the strategy: Substantially decrease the prevalence and death rate of cancer, which is a major cause of death in Japan, through comprehensive promotion of research, prevention, and treatment.

## Promotion of cancer research

(1) Rapid promotion of research to elucidate the nature of cancer with cross-scientific ideas and through introducing the latest science and technology.

(2) Promotion of translational research for active utilization of basic research results in prevention, diagnosis, and treatment

(3) Development of innovative prevention methods

## Promotion of cancer prevention

(4) Development of innovative diagnostic/treatment methods

(5) Identification of the actual situation with cancer and distribution and dissemination of cancer information/treatment technologies

Improved social environment with improved cancer medical care and support

## Substantial decrease in the prevalence/death rate of cancer

(1) Establishment of effective cancer prevention methods

(2) Promotion of knowledge dissemination on cancer prevention

(3) Improved preventive measures against cancer caused by infectious diseases

(4) Early discovery/treatment of cancer

(1) Improved cancer research/treatment functions of core facilities

(2) "Eeualization" of cancer medical services

(3) Improved quality of life (QOL) for cancer patients

(4) Promotion of international cooperation/exchanges and cooperation between industry, the government, and academia
Detailed Data Statistics on Cancer (as of March 1, 2012)

Item	Current status	Source
Number of deaths	Total of 357,185 persons (28.5% of all causes of death)[213,109 males (32.5% of all causes of death)][144,076 females (24.1% of all causes of death)]→ “1 in every 3.5 Japanese die of cancer”* Risk of cancer increases with age→ The gross number of deaths is increasing (effect of aging)* The age-adjusted mortality are (younger than 75) is on a declining trend since 1995 (108.4 in 1995 → 84.3 in 2010)* Types of cancers are changing	Vital Statistics of Japan (Annual total of monthly reports in 2011 (approximates))(Recounted by the Center for Cancer Control and Information Services, National Cancer Center)
Incidence rate	743,664 persons[427,949 males]Major sites: stomach, large intestine, liver, and prostate gland, and liver[315,715 females]Major sites: breast, large intestine, stomach, lung, and uterine cervix* Including esophageal, colon, lung, skin, breast, uterine cervix, and carcinoma in situ bladder cancer	Estimates based on population-based cancer registry (2007)
Lifetime risk	Male 54%, Female 41%→ “1 in every 2 persons will contract cancer in Japan”	Estimates by Center for Cancer Control and Information Services, National Cancer Center (2005)
Patients and persons receiving treatment	The number of persons requiring constant treatment was 1.52 million• The number of persons hospitalized at the time of the survey was 141,400• The number of outpatients was 156,400• 297,800 persons received treatment per day (3.6% of those receiving treatment)	Patient Survey (2008)
Medical care expenditure for cancer	¥2,957.7 billion* 11.1% of total general medical care expenditure	Estimates of National Medical Care Expenditure (2009)
## Overview Outline of Intractable Disease Measures

Various projects have been implemented in accordance with the "Outline of Intractable Disease Measures" compiled in 1972.

Research Project on Overcoming Intractable Diseases

$ ^{*1} $ Diseases subjected to focused research and cross-sectional basic research are the same as those subjected to clinical investigations/research.

$ ^{*2} $ In addition to the 56 diseases the research project on the treatment of specified diseases includes the research project on hemophilia treatment, etc.
## Overview Outline of Tuberculosis Prevention Measures

A. Regular physical checkups (tuberculin test, X-ray test, etc.)	Elderly, (high school) students, employees working at school and hospitals, and facility residents
B. Regular preventive vaccination (BCG)	Infants younger than 6 months old
C. Patient management	Notification	At the time of diagnosis, at the beginning/end of hospitalization
Registration	Tuberculosis registration cards, identification of the current situation of patients
Health guidance	Home-visit, public health education, etc.
Screening for proper disease management	Persons requiring follow-ups, patients who have suspended treatment, etc.
D. Infection prevention	Work restriction, etc.	Restricting patients who may transmit diseases to others from working, recommendation/order for hospitalization
Sterilization, etc.	Sterilization of houses/buildings, sterilization and disposition of goods
On-site investigatio	Investigation of patients, etc.
E. Medical care (public fund)	Hospitalization care	Medical care expenses for tuberculosis patients who have been given recommendation/order for hospitalization
Proper medical care	Medical fees for promoting proper medical care for tuberculosis

Detailed Data 1 Changes in Number of Newly Registered Tuberculosis Patients, Prevalence Rate, and the Number of Deaths

Number of newly registered patients	Prevalence rate	Number of deaths	Rate of deaths
(Person)	(To the population of 100,000)	(Person)	(To the population of 100,000)
1960	489,715	524.2	31,959	34.2
1965	304,556	309.9	22,366	22.8
1970	178,940	172.3	15,899	15.4
1975	108,088	96.6	10,567	9.5
1980	70,916	60.7	6,439	5.5
1985	58,567	48.4	4,692	3.9
1990	51,821	41.9	3,664	3.0
1995	43,078	34.3	3,178	2.6
1999	43,818	34.6	2,935	2.3
2000	39,384	31.0	2,656	2.1
2001	35,489	27.9	2,491	2.0
2002	32,828	25.8	2,317	1.8
2003	31,638	24.8	2,337	1.9
2004	29,736	23.3	2,330	1.8
2005	28,319	22.2	2,296	1.8
2006	26,384	20.6	2,269	1.8
2007	25,311	19.8	2,194	1.7
2008	24,760	19.4	2,220	1.8
2009	24,170	19.0	2,159	1.7
2010	23,261	18.2	2,129	1.7
2011	22,681	17.7	2,162	1.7

Source: “Aggregate Result of the Annual Reports of Surveillance of Tuberculosis”, Health Service Bureau, MHLW

“Vital Statistics”, Statistics and Information Department, Minister's Secretariat, MHLW

(Note) 1. The figures for 1998 and later do not include those of atypical mycobacteria positive.

2. The number of deaths and the rate of deaths for 2011 are approximates.
Tuberculosis Prevalence Rate by Prefecture (as of the end of 2011)

Prefecture	Prevalence rate
5 prefectures with the lowest prevalence rate	Iwate	8.9
Miyagi	9.8
Nagano	10.1
Gunma	11.2
Yamagata	11.3
5 prefectures with the highest prevalence rate	Osaka	28.0
Tokushima	23.6
Wakayama	23.5
Tokyo	22.9
Gifu	21.0

International Comparison of Tuberculosis Prevalence Rate

Country	Prevalence rate	Year
U.S.A.	4.1	2010
Canada	4.7	2010
Sweden	6.8	2010
Australia	6.3	2010
Netherlands	7.3	2010
Germany	4.8	2010
Denmark	6.0	2010
Italy	4.9	2010
France	9.3	2010
U.K.	13.0	2010
Japan	17.7	2011

Source: Global Tuberculosis Control WHO Report 2011
## Overview

AIDS control measures
## 3 important areas on which measures should be focused

## Dissemination, enlightenment, and education

• Provision of basic information and correct knowledge on HIV/AIDS

• Development of and preparation of manuals on dissemination/enlightenment methods

• Measures for young people and homosexuals

## I mprovement of test/consultation system

• Establishment of HIV test promotion week (June 1 to 7 every year)

• Reformation of test/consultation information provision system

• Development of test methods, preparation of manuals on test/consultation methods

• Establishment of more accessible test system (night time on weekdays, holidays, quick test, etc.)

## Reformation of medical care provision system (380 core hospitals)

• Establishment of outpatient team medical care

• Discussion on hospital-clinic cooperation → creation of hospital-clinic cooperation model projects

• Securing medical care system in prefectures, including establishment of core hospitals

## New methods to support implementation of measures

○Enhanced cooperation with NGOs for implementing measures, including dissemination and enlightenment

○Promotion of comprehensive AIDS control measures through conducting regular conference among relevant ministries and agencies

○Focused support for prefectures, etc. with consideration given to policy evaluations

→ Focused cooperation with prefectures, etc. (17 local governments) with large number of infected persons/patients
Quasi-drugs

New quasi-drugs: Approved by MHLW based on equivalency evaluation and examination for approval conducted by the Pharmaceuticals and Medical Devices Agency

Items meeting approval standards: Approved by prefectural governors

Other items: Approved by MHLW based on equivalency evaluation and examination for approval conducted by the Pharmaceuticals and Medical Devices Agency

(Medicated toothpastes, hair dyes, bath products, mouth washes, etc.)

Items labeling all ingredients: Application for approval exempted, notification to prefectural governors required on individual items after acquiring manufacturing/marketing approval

Items containing ingredients not required for labeling: Approved by MHLW based on equivalency evaluation and examination for approval conducted by the Pharmaceuticals and Medical Devices Agency

## Flow of Examination for the Approval of a New Drug

(Note) The trials that are deemed necessary for application for the approval of a new drug can be roughly divided into two categories: preclinical (physical/chemical tests and animal tests) and clinical trials. Clinical trials are conducted on a phased basis from phase I trial (a small number of healthy volunteers), the phase II trial (a small number of patients), and the phase III trial (a large number of patients), as indicated in the chart above.

## [Examination for the approval of a new drug]

The quality, efficacy, and safety of a new drugs require an especially careful review. Therefore, a mechanism is in place in which the Pharmaceutical Affairs and Food Sanitation Council (an advisory organ to the Minister of Health, Labour and Welfare) composed of experts in the fields of medical science, pharmaceutical science, veterinary science, and statistical science deliberates on these subjects based on a number of data derived from basic and clinical studies. This mechanism also includes the decision making process in which the Minister of Health, Labour and Welfare makes decisions on the approvals of a new drug based on the results of the deliberations of the Council.

Good Laboratory Practices (GLP) for the implementation of animal testing (against toxicity) among non-clinical tests and Good Clinical Practices (GCP) for the implementation of clinical tests are set forth by ministerial ordinances. Each test is regulated by GLP and GCP to assure appropriate testing.

### [License for marketing and manufacturing drugs, etc.]

The approval and licensing system for drugs, etc. was revised. Since April 2005, the system has been applied separately to a marketing authorization holder that ships products to markets and to a manufacturer of the products.

To obtain a license, a marketing authorization holder will be reviewed whether it complies with the standards on quality control procedures, as well as post-marketing safety control procedures. A manufacturer will be reviewed whether it compiles with the standards on structure and facilities of manufacturing sites and on quality control procedures.

Prefectural governors issue the license for marketing and that for manufacturing, except for manufacturing of some drugs that require sophisticated manufacturing technology.
## Detailed Data 1 Number of Licenses for Marketing Authorization Holder of Drugs, etc

(As of the end of 2011)

Category	Drugs	Quasi-drugs	Cosmetics	Total
Class 1 drugs	Class 2 drugs
Marketing	1,212	253	959	1,331	3,404	5,947

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) Licenses are granted by prefecturel governors (from April 1, 2005).

Detailed Data 2 Number of Approvals for Manufacturing/Import/Marketing Drugs, etc. (2011)

Prescription drugs	Over-the-counter drugs	Quasi-drugs	Cosmetics
Manufacturing	Approval	0	5	0	0
Approval with partial revision	65	3	0	0
Total	65	8	0	0
Import	Approval	0	2	0	0
Approval with partial revision	8	0	0	0
Total	8	2	0	0
Marketing	Approval	1,173	744	1,643	0
Approval with partial revision	2,107	281	291	0
Total	3,280	1,025	1,934	0

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) Excluding in vitro diagnostics.

## Detailed Data 3 Number of Approvals for Manufacturing Drugs, etc

(As of the end of 2011)

Category	Drugs	Quasi-drugs	Cosmetics	Total
Manufacturing	2,414	1,641	3,374	7,429

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) Licenses are granted by prefecturel governors from April 1, 1995 (excluding some drugs)
Overview Review for the Approval of Medical Devices

Detailed Data 1 Number of Licenses for Marketing Authorization Holder of Medical Devices

(As of the end of 2011)
Category	Class 1 medical devices	Class 2 medical devices	Class 3 medical devices	Total
Marketing	616	925	927	2,468

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) Licenses are granted by prefecturel governors (from April 1, 2005).

Detailed Data 2 Number of Approvals for Manufacturing, Import, and Marketing Medical Devices (2011)

Medical devices
Manufacturing	Approval	0
Approval with partial change	10
Total	10
Import	Approval	73
Approval with partial change	21
Total	94
Marketing	Approval	632
Approval with partial change	536
Total	1,168

Source: Pharmaceutical and Food Safety Bureau, MHLW

## Detailed Data 3 Number of Licenses for Manufacturing Medical Devices, etc

Medical devices
Manufacturing	3,571
Repairs	6,268

Source: Pharmaceutical and Food Safety Bureau, MHLW (as of the end of 2011)

(Note) Licenses are granted by prefecture governors from April 1997 (excluding some medical devices).
Post-Marketing Safety Measures for Drugs

Flow of Post-Marketing Surveillance and Re-examination/Re-evaluation of Drugs

Outline of the Adverse Drug Reaction, etc. Reporting System

*1: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

*2: Global Harmonization Task Force (transfer to IMDRF (International Medical Device Regulators Forum) planned for 2013)
## Results of Prescription Drug Re-examination

(As of the end of FY2011)

Drugs that are approved for effectiveness	Drugs that can be approved for effectiveness with partial revision of matters to be approved	Drugs that are not approved for effectiveness
Number of ingredients	Number of items	Number of ingredients	Number of items	Number of ingredients	Number of items
1,107	3,058	50	142	0	0

Source: Pharmaceutical and Food Safety Bureau, MHLW

## Results of Prescription Drug Re-evaluation

(As of the end of FY2011)

Comprehensive evaluation (number of items)
Drugs that are approved for effectiveness	Drugs that can be approved for effectiveness with partial revision of matters to be approved	Drugs that are not approved for effectiveness	Drugs that the applicants made adjustments on matters to be approved after filing re-evaluation application	Total
Phase 1 re-evaluation	11,098	7,330	1,116	305	19,849 (19,612)
Phase 2 re-evaluation	105	1,579	42	134	1,860
New re-evaluation	4,608	3,315	66	864	8,853

Source: Pharmaceutical and Food Safety Bureau, MHLW

(Note) 1. The figures in parentheses indicate those adjusted for cases where the same item was officially announced more than once.

2. Phase 1 re-evaluation: covers ingredients approved on or prior to September 30, 1967

3. Phase 2 re-evaluation: covers ingredients approved between October 1, 1967 and March 31, 1980

4. New re-evaluation: covers all ingredient

## Detailed Data 3

Changes in the Number of Reports on Adverse Drug Reaction, etc. in the Past 5 Years

(Unit: case)

FY	Reports from marketing authorization holders	Reports on adverse drug reactions from medical professionals
Reports on adverse drug reactions	Reports on research results	Reports on overseas measures	Regular reports on infectious diseases	4 vaccines*
2007	28,231	858	695	1,092	3,891
2008	31,455	855	869	1,074	3,839
2009	30,814	933	930	1,108	3,721	2,460
2010	34,578	940	1,033	1,101	3,656	1,153
2011	36,641	841	1,347	1,089	3,388	1,843

$ ^{*} $ 4 vaccines: Reports consolidated by MHLW on adverse reactions arising from voluntary inoculation of influenza vaccines (including novel type) or its inoculation with vaccination promotion project under the Preventive Vaccinations Act and those arising from emergency vaccination promotion projects involving cervical cancer prevention vaccines, Hib vaccines, pneumococcus vaccines for children.

Source: Pharmaceutical and Food Safety Bureau, MHLW

Changes in Number of Reports on Adverse Event Related to Medical Devices, etc. in the Past 5 Years

(Unit: case)

FY	Reports from marketing authorization holders	Reports on adverse event from medical professionals
Reports on adverse event	Reports on research results	Reports on overseas measures	Regular reports on infectious diseases
2007	16,550	15	525	52	434
2008	6,351	10	748	64	410
2009	6,446	6	831	59	363
2010	14,811	27	978	58	374
2011	16,068	2	1,060	62	385

Source: Pharmaceutical and Food Safety Bureau, MHLW
# Relief Systems for Adverse Drug Reactions and Infections Acquired through Biological Products

## Overview

## [Relief System for Adverse Drug Reactions]

The purpose of this system is to provide various relief benefits and prompt relief to patients and their families, apart from civil liability, in relation to injury caused by adverse reactions despite the proper use of drugs.

## [Relief System for Infections Acquired through Biological Products]

The purpose of this system is to provide various relief benefits and prompt relief to patients and their families, apart from civil liability, in relation to injury caused by infections despite the proper use of biological products.

## [Responsible organization]

Pharmaceuticals and Medical Devices Agency

[Types of Relief Benefits]

## [Activities on the Relief for Caused Damages]

The Agency has been commissioned by pharmaceutical enterprises and the government to pay health management allowances, etc. to SMON (subacute myelo-optico-neuropathy) patients who have settled the lawsuit out of court.

### [Relief Program for AIDS patients, etc. caused by Blood Products]

A survey and research project has been conducted since FY 1993 for helping HIV carriers infected through the use of contaminated blood products to prevent them from developing symptoms. For the prevention of the onset of AIDS and for health management in daily life, the government provides health management expenses and in turn requests the carriers report their health status.

Since FY 1996, assistance on health management expenses has been provided for the health management of those who developed AIDS and accepted the court settlement.

Changes in Status of Adverse Drug Reaction Relief Payments (as of the end of each FY)

FY1980 -1996	FY1997	FY1998	FY1999	FY2000	FY2001	FY2002	FY2003	FY2004	FY2005	FY2006	FY2007	FY2008	FY2009	FY2010	FY2011
Amount (¥1,000)	6,058,217	797,557	928,986	920,419	935,148	1,022,185	1,055,985	1,204,243	1,262,647	1,587,567	1,582,956	1,696,525	1,798,706	1,783,783	1,867,190	2,058,389
Number of claims (case)	2,665	399	361	389	480	483	629	793	769	760	788	908	926	1,052	1,018	1,075
Number of payments (case)	2,076	294	306	289	343	352	352	465	513	836	676	718	782	861	897	959

Source: Pharmaceutical and Medical Devices Agency
Detailed Data Breakdown of Marketing Authorization Holders of Drugs, etc. by Scale

Category	Number of enterprises	Percentage	Drug sales (¥100 million)	Percentage	Prescription drug sales (¥100 million)	Percentage
Capital of less than ¥100 million	188	50.0%	3,377	2.9%	1,839	2.0%
¥100 million - 5 billion	128	34.0%	30,382	25.8%	23,840	26.3%
¥5 billion or more	60	16.0%	83,934	71.3%	65,028	71.7%
Total	376	100.0%	117,693	100.0%	90,707	100.0%

Source: “Survey of the Prescription Pharmaceuticals Industry of Japan (FY2010)”, Health Policy Bureau, MHLW (Note) Survey targets were enterprises marketing drugs with approval of marketing authorization under the Pharmaceutical Affairs Act as of March 31, 2011 that were members of categorized organizations (14 organizations) of the Federation of pharmaceutical Manufacturers' Association of Japan.