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1. Drug Regulatory Agencies In
JAPAN
Presented by- Co-Presented by-
Namrata Mange Sulabh Singhania
M.Pharm – 2nd SEM M.Pharm- 2nd SEM
DEPARTMENT OF PHARMACEUTICS
E.No:-201504100410005 E.No:- 201504100410019
2. Drug regulatory agency of Japan
• Ministry Of Health, Labour And Welfare
(MHLW )
• Pharmaceutical and Medical devices
Agency(PMDA)
23/30/2016
4. Pharmaceutical and Medical
devices Agency (PMDA)
• PMDA continues to improve the public health and safety of
Japan by reviewing applications for marketing approval of
pharmaceuticals and medical devices, conducting safety
measures, and providing relief to people who have suffered
from adverse drug reactions.
43/30/2016
5. Principle
• They make science-based judgments on quality, safety, and
efficacy of medical products by training personnel to have the
latest technical knowledge and wisdom in their field of
expertise.
• They play an active role within the international community
by promoting international harmonization.
• They conduct services in a way that is trusted by the public
based on our experiences from the past.
• They will be the bridge between the patients and their
wishes for faster access to safer and more effective drugs and
medical devices. 53/30/2016
6. Who is PMDA
• PMDA (Pharmaceuticals and Medical Devices Agency) is
Japanese regulatory agency, working together with Ministry of
Health, Labor and Welfare.
• Their obligation is to protect the public health by assuring
safety, efficacy and quality of pharmaceuticals and medical
devices.
• They conduct scientific reviews of marketing authorization
application of pharmaceuticals and medical devices,
monitoring of their post-marketing safety.
• They are also responsible for providing relief compensation
for sufferers from adverse drug reaction and infections by
pharmaceuticals or biological products.
3/30/2016 6
7. History
• Following the Reorganization and Rationalization Plan for
Special Public Corporations that was approved in a Cabinet
meeting in 2001, the Pharmaceuticals and Medical Devices
Agency (PMDA) was established and came into service on
April 1, 2004, under the Law for the Pharmaceuticals and
Medical Devices Agency.
• As a consolidation of the services of the Pharmaceuticals and
Medical Devices Evaluation Center of the National Institute of
Health Sciences (PMDEC), the Organization for
Pharmaceutical Safety and Research (OPSR/KIKO), and part of
the Japan Association for the Advancement of Medical
Equipment (JAAME).
3/30/2016 7
10. Regulations and Services
Post-marketing Safety Measures
• We collect safety information, such as adverse drug reactions,
infections caused by use of pharmaceuticals and medical
devices and adverse events caused by medical devices from
companies and healthcare professionals. That information is
stored into a database for scientific analysis and investigation.
Findings from investigation are reported to the MHLW, which
would result in administrative actions to ensure safety use of
pharmaceuticals and medical devices, etc.
3/30/2016 10
11. • We provide information on pharmaceuticals and medical
devices on the website in order to promote their proper use,
by listing package inserts, product recalls, drug guide for
patients and other urgent safety alerts as well as reports on
adverse drug reactions and adverse events of medical devices
submitted to the PMDA from companies.
• We also offer free e-mail information delivery services
providing latest safety information to the health care
professionals.
3/30/2016 11
12. • We provide telephone consultation services on
pharmaceuticals and medical devices for consumers, etc.
• We collect safety measure contributions from marketing
authorization holders of pharmaceuticals and medical
devices.
• We develop and implement new methods and techniques for
post-marketing safety operations, such as data mining
method and sentinel medical institution network, with a view
to enhancing quick response to problems and taking accurate
safety measures. Thus it enables us to prevent and predict
safety problems.
3/30/2016 12
14. Relief Services for Adverse Health Effects
• We have "Adverse Drug Reaction Relief System" to
compensate for death or health damages requiring
hospitalization, caused by appropriately used prescribed and
purchased drugs.
• We have "Relief System for Infections Derived from Biological
Products" to compensate death, health damages requiring
hospitalization caused by infections from appropriately used
biological products.
• We provide "Healthcare Allowance" to SMON patients under
the commission of Japanese government and pharmaceutical
companies.
3/30/2016 14
15. • We also provide "Healthcare Allowance" to HIV-positive and
AIDS patients under the commission of the Yu-ai Welfare
Foundation.
• We provide compensations in accordance with "the Special
Measures Law concerning the Payment of Benefits to Relieve
the Patients of Hepatitis C Infected through Specified
Fibrinogen Preparations and Specified Blood-Coagulation
Factor IX Preparations Contaminated by Hepatitis C Virus."
3/30/2016 15
17. Drug and Medical Device Reviews
• Scientific reviews of pharmaceuticals and medical devices
for marketing authorization based on the Pharmaceutical
Affairs Law of Japan
• Consultation (Planning and implementation of clinical trials
and preparation of NDA dossiers, etc.) - GCP / GLP / GPSP
inspections and conformity audit on dossiers submitted as
initial application, re-examination and re-evaluation
application
• GMP / QMS inspections on manufacturing sites, processes
and quality management system of pharmaceuticals and
medical devices
• Confirmation of re-examination and re-evaluations based on
the Pharmaceutical Affairs Law3/30/2016 17
18. GLP / GCP / GPSP Compliance
Assessments
• PMDA conducts inspections and data integrity assessments in
relation to applications for marketing approval, re-
examination, re-evaluation, or use-results evaluation of a
product to assess whether the tests and clinical trials have
been conducted in an ethically and scientifically appropriate
way.
• In compliance with Good Laboratory Practice (GLP), Good
Clinical Practice (GCP) and Good Post-Marketing Surveillance
Practice (GPMSP) or Good Post-marketing Study Practice
(GPSP), and whether the submitted data comply with the data
integrity standards for regulatory submission documentation.
PMDA also provides GLP compliance certification to testing
laboratories
3/30/2016 18
19. GMP / QMS / GCTP Inspections
• GMP inspection
– For GMP inspection, PMDA conducts on-site and
document- based inspections of manufacturing sites for
products classified as “high-risk,” such as new drugs,
biological products or biotechnological products
(including foreign manufacturing sites), in order to
ascertain whether their manufacturing facilities and
manufacturing and quality controls comply with standards
such as the Good Manufacturing Practice (GMP), and
whether the manufacturing sites have a system for
manufacturing products of adequate quality.
PMDA also conducts inspections in relation to
accreditation of foreign manufacturers.
3/30/2016 19
20. QMS inspection
• For medical devices and in vitro diagnostics, PMDA conducts
on-site and document-based inspections of the registered
manufacturing sites (of products under review or approved
products) located in Japan or overseas, in order to ascertain
whether their manufacturing facilities and manufacturing and
quality controls comply with standards.
• Such as the Quality Management System (QMS), and
whether the manufacturing sites have a system for
manufacturing products of adequate quality.
3/30/2016 20
21. GCTP inspection
• PMDA has established a system to inspect manufacturing sites
of cellular and tissue-based products located in Japan or
overseas, in order to determine whether their manufacturing
facilities as well as manufacturing process and quality
management system comply with the Good Gene, Cellular,
and Tissue-based Products Manufacturing Practice (GCTP).
• PMDA has also developed a necessary system for inspections
on compliance with the standards for buildings and facilities,
and for-cause inspections and questioning for cell processing
facilities, which will be newly started by the enforcement of
the Act on Securing Safety of Regenerative Medicine.
3/30/2016 21
23. History
• The MHLW, which was originally established in 1938, has
been in charge of the improvement and promotion of
social welfare, social security and public health.
• The ministry proper includes the Minister's Secretariat,
11 bureaus, and the Director-General for Policy Planning
and Evaluation.
• It handles clinical studies, approval reviews and post-
marketing safety measures, i.e., approvals and licensing.
233/30/2016
24. Conti…
• Closely related to the people’s lives-from birth to
employment to the security of old age.
• Its activities encompass various phases of life such as
medical services, public health, working
environment, employment security, human
resources development, child care, long-term Care,
welfare and pensions.
• It is committed to the development of policies that
will bring “security” and “activity ”to people’s daily
lives.
243/30/2016
25. Functions of MHLW
• Social Welfare :
• Social Security :
• Human Resources Development :
• Public Hygiene :
• Job Security :
• Working Environment :
253/30/2016
26. Names of Ministry of Health, Labour and
Welfare Organizations
(1)Minister‘s Secretariat
(2)Pharmaceutical & Food Safety Bureau
(3)Health Policy Bureau
(4)Health Service Bureau
(5)Worker's Compensation Department
(6)Industrial Safety and Health Department
(7)Employment Security Bureau
263/30/2016
27. Conti….
(8)Social Welfare and War Victims' Relief Bureau
(9)Human Resource Development Bureau
(10)Health and Welfare Bureau for the Elderly
(11)Health Insurance Bureau
(12)Pension Bureau
(13)Social Insurance Agency
(14)Central Labour Relations Commission
273/30/2016
28. Pharmaceutical and Food Safety Bureau
Functions
• The work of this Bureau involves Controlling the
production and sales of drugs,cosmetics and medical
devices, and collecting/offering information on
adverse reactions from products in order to ensure
effectiveness and safety.
• It also contributes to the healthy life of society by
controlling narcotics stimulant abuse and ensuring
chemical safety.
283/30/2016
29. Health Policy Bureau
Functions
• The Health Policy Bureau works to plan and design
medical policy that will ensure that qualified and
effective medical services are available for people
suffering from disease or injury.
• It also supports research and development and
industries in the field of medical supplies and
medical devices .
293/30/2016
30. Health Service Bureau
Functions
• The Health Service Bureau promotes local health-
care through health centers. It is working to control
infectious diseases
(Fever,Aids,tuberculosis,etc),lifestyle-related diseases
(cancers, diabetes,etc),and other areas such as
incurable diseases,allergies,as well as the
deployment of appropriate organ transplantations.
• It also works to ensure that people are able to lead
hygienic and comfortable lives .
303/30/2016
31. Workers’ Compensation Department
Functions
• This Department is working to support workers and
bereaved families who have been the victims of
industrial accidents by offering them immediate
compensation.
• It is also enforcing the general rehabilitation plan for
workers who have suffered industrial accidents and
providing nursing care-centres for those workers
seriously injured at work.
313/30/2016
32. Industrial Safety and Health
Department
Functions
• In order to ensure a working environment which is
safe and healthy.
• The Industrial Safety and Health Department is
deploying the industrial accident prevention plan.
• It is also working to prevent occupational diseases
and to promote healthy working environments for all
worker.
323/30/2016
33. Employment Security Bureau
Functions
• It mainly do reemployment of worker, employment
creation in the newly born industries and to bridge
the gap between supply and demand in the labour
market.
• These measures will relieve people’s anxieties about
future unemployment, and again create a society
with hope and vitality.
333/30/2016
34. Social Welfare and War Victims’ Relief
Bureau
Function
• This Bureau is working towards the planning and
managing the basic systems common in each area of
social welfare including the social welfare foundation
system, welfare offices, community chests, securing
human resources for social welfare
• Its public assistance services are wide-ranging and
include the planning and management of the welfare
system.
343/30/2016
35. Human Resources Development
Bureau
Function
• This Bureau is implementing the human resources
development policies which deal with changes in the
industrial structure brought about by the introduction
of IT,changes in economic and social trends such as the
diversification in working styles.
• It also aims to secure employment opportunities
through the promotion of human resources
development undertaken by workers
themselves,supporting training programs conducted by
employers.
353/30/2016
36. Health and Welfare Bureau for the
Elderly
Functions
• In order to help elderly people lead an
independent, dignified lives and to participate in
social activities in an aging society.
• This Bureau manages the smooth
implementation of the long-term care insurance
system.
• It is also working to implement the provisions
contained in “Long-Term Insurance Project and
promoting various projects for elderly people to
help them obtain a high quality of life.
363/30/2016
37. Health Insurance Bureau
function
• The Health Insurance Bureau’s work includes the planning
and establishing of various medical insurance systems such
as Employees’ Health Insurance, National Health Insurance,
and Health Insurance System for the Latter-Stage Elderly.
Pension Bureau
function
• The Pension Bureau is working to establish and operate a
sustainable pension system that is truly trusted by people and
which contributes to the security of people’s lives by planning
for and operating a public pension system that supports the
post-retirement lives of the people 373/30/2016
