its about the regulatory agencies all over the world

1. PREPARED BY:
PRIYANKA CHAKOTE.

2.  Meaning
 Introduction
 Key function
 Agencies in INDIA
 Agencies in US
 Agencies in JAPAN
 Agencies in EU
 ICH
 References

3. Drug
“All medicines for internal or external use of
human beings or animals and all substances
intended to be used for diagnosis, treatment,
mitigation or prevention of any disease or
disorder in human beings or animals.”
Regulation
“To regulate means to control something
so that it functions properly”.

4.  Drugs play important role in the health and economy of a
country.
 Pharmaceutical drugs are available from number of
source.
 To ensure that that they meet prescribed standards.
 To ensure the safety, efficacy and quality of drugs as well
as accuracy and appropriateness of the drug information
available to the public.

5.  Product registration.
 Regulation of drug manufacturing, importation , and
distribution.
 Adverse drug reaction monitoring.
 Licensing of premises & persons & practices.
 Main goal of the agency is to guarantee the safety ,
efficacy, and quality of the available drug product .

6. DRUG
REGULATION
QUALITY
CONTROL
DRUGS
LAWS .
DRUG
REGULATORY
BOARDS
DRUG
REGULATORY
AGENCY
DRUG
INFORMATION
CENTER

7.  Central Drug Standard Control Organization (CDSCO)
 Ministry Of Health & Family Welfare (MHFW)
 Indian Council Of Medical Research (ICMR)
 Indian Pharmaceutical Association (IPA)
 Drug Technical Advisory Board (DTAB)
 Central Drug Testing Laboratory (CDTL)
 Indian Pharmacopoeia Commission (IPC)
 National Pharmaceutical Pricing Authority (NPPA)

10.  To approve license to the various manufacturing of certain
categories of drug as central licensing approving authorities i.e.
For Blood Banks, Large Volume Parental And Vaccines And Sera.
 To regulate the standards of the imported drug products.
 Work Relating To The Drug Technical Advisory Board (DTAB)
And Drugs Consultative Committee.
 Testing Of Drugs By Central Drugs Lab.
 Publication Of The Indian Pharmacopeia.

11. MAIN BODIES
 The Food And Drug Administration (FDA).
 National Institute Of Health (NIH).
 Centers For Disease Control And Prevention .
 Department Of Health And Human Service (DHHS).
 Fed World Us Information .
 National Center For Complementary And Alternative
Medicine (NCCAM).

12. The Food and Drug Modernization Act states
that the FDA has 4 roles:
 To promote health by reviewing research and approving
new products.
 To ensure foods and drugs are safe and properly labeled.
 To work with other nations to “reduce the burden of
regulation”.
 To cooperate with scientific experts and consumers to
effectively carry out these obligations.

13. FDA
The Office of
the
Commissioner
(OC)
The Center for
Drug Evaluation
and Research
(CDER)
The Center for
Biologics
Evaluation and
Research
(CBER)
The Center for
Food Safety and
Applied
Nutrition
(CFSAN)
The Center for
Devices and
Radiological
Health
(CDRH)
The Center
for
Veterinary
Medicine
(CVM)
The National
Center for
Toxological
Research (NCTR)
The Office of
Regulatory
Affairs (ORA)
Center for
tobacco
product

14.  Protecting the public health by Assuring that the food
products are safe.
 Assuring human and veterinary drugs, and vaccines and
other biological products and medical devices intended for
human use are safe and effective.
 Protecting the public from electronic product radiation.
 Assuring cosmetics and dietary supplements are safe and
properly labeled.
 Advancing the public health by helping to speed product
innovations.
 Helping the public get the accurate science-based
information they need to use medicines, devices, and foods
to improve their health.

15. MAIN BODIES:
 Ministry of Health and Welfare
 National Institute of Infectious Diseases
 National Institute of Health Sciences

16.  In January 1938, the Ministry of Health and Welfare
was established by integrating the administrations of the
Sanitary Bureau and the Social Affairs Bureau in the
Ministry of Home Affairs.
 In September 1947 The Ministry of Labour was
established by integrating labour administrations that
had previously been conducted by the Ministry of Health
and Welfare.

17. 17
MHLW
Social insurance
agency
Ministry proper
Minister’s
secretariat
Heath policy
bureau
Heath service
bureau
PFSB
Social welfare &
war victim’s relief
bureau
Health and welfare
bureau for elderly
Equal employment
children & family
bureau
Insurance bureau
Pension bureau
Director general
for policy planning
Social insurance
agency
Ministry proper
PFSB
Social welfare &
war victim’s relief
bureau
Health and welfare
bureau for elderly
Equal employment
children & family
bureau
Insurance bureau
Pension bureau
Director general
for policy planning

18.  Social Welfare :
 Services for elderly people
 Services for persons with disabilities
 Social Security :
 Pension systems that will ensure income in elderly age
 Long term insurance to provide nursing care services
 Public assistance systems that guarantee minimum standards.

19.  Public Hygiene :
 Appropriate medical services
for diseases & injuries
 Ensuring the safety of food,
Water and medical supplies
 Research into health science
in order to make
technological advances
 Maternal and child health
 Job Security :
 Promotion of
employment
 Employment of elderly
people
 Employment of persons
with disabilities
 Management of the
employment insurance
system

20.  MAIN BODIES:
 EU Legislation - Eudralex
 European Directorate for the Quality of Medicines and
Healthcare (EDQM)
 European Medicines Agency (EMEA)
 Heads of Medicines Agencies (HMA)

21.  The EDQM (Council of Europe) is a key European
Organisation involved in Harmonisation & Co-ordination of
Standardisation, Regulation & Quality Control of Medicines,
Blood Transfusion, Organ Transplantation, Pharmaceuticals
and Pharmaceutical Care.
 In 1996 The European Directorate for the Quality of
Medicines (EDQM) is created.

22.  To contribute to the basic human right of access to
good quality medicines and healthcare and to promote
and protect human and animal health by:
 Establishing and providing official standards which
apply to the manufacture and quality control of
medicines in all signatory States of the "Convention on
the Elaboration of a European Pharmacopoeia" and
beyond;
 Ensuring the application of these official standards to
substances used in the production of medicines.

24.  EMA is a European agency for the evaluation of medicinal
product.
 EMA was set up in 1995.
 From 1995 to 2004, EMA was known as European agency for
the evaluation of medicinal product.
 The European Medicines Agency (EMA) is a decentralized
body of the European Union, located in London
 Mission: to foster scientific excellence in evaluation and
supervision of medicines

25.  Provides independent, science-based recommendations
on the quality, safety and efficacy of medicines.
 Applies efficient and transparent evaluation procedures
to help bring new medicines to the market.
 Implements measures for continuously supervising the
quality, safety and efficacy of authorised medicines.
 Provides scientific advice to stimulate the development
and improve the availability of innovative new medicines