PREPARED BY:

PRIYANKA CHAKOTE.

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

Drug“All medicines for internal or external use of

human beings or animals and all substancesintended to be used for diagnosis, treatment,mitigation or prevention of any disease ordisorder in human beings or animals.”

Regulation“To regulate means to control something

so that it functions properly”.

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.

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 .

DRUG

REGULATION

QUALITY CONTROL

DRUGS LAWS .

DRUG REGULATORY

BOARDS

DRUG REGULATORY

AGENCY

DRUG

INFORMATION

CENTER

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)

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.

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).

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.

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

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.

MAIN BODIES:

Ministry of Health and Welfare National Institute of Infectious Diseases National Institute of Health Sciences

In January 1938, the Ministry of Health and Welfarewas established by integrating the administrations of theSanitary Bureau and the Social Affairs Bureau in theMinistry of Home Affairs.

In September 1947 The Ministry of Labour wasestablished by integrating labour administrations thathad previously been conducted by the Ministry of Healthand Welfare.

17

MHLWSocial 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

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.

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

MAIN BODIES:

EU Legislation - Eudralex

European Directorate for the Quality of Medicines and Healthcare (EDQM)

European Medicines Agency (EMEA)

Heads of Medicines Agencies (HMA)

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.

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.

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

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