Thursday, November 1, 2012

Major Drug Regulatory Agencies World Wide

 Pharmaceutical companies and regulatory agencies work together to enhance patient safety when a medicine is first being studied (pre-approval) and after it becomes available to patients and their health care providers as a treatment option, following authorization by regulatory agencies (post-approval). 
Regulatory agencies are government or non-government authorities, responsible for oversight of the effectiveness, safety, manufacture, and distribution of medicines in a specific country or region of the world such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.


List of drug regulatory agency :

Country

Name of Regulatory Authority

USA
Food and Drug Administration (FDA)
UK
Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia
Therapeutic Goods Administration (TGA)
India
Central Drug Standard Control Organization (CDSCO)
Canada
Health Canada
Europe
European Medicines Agency (EMEA)
Denmark
Danish Medicines Agency
New Zealand
Medicines and Medical Devices Safety Authority (Medsafe)
Sweden
Medical Products Agency (MPA)
Netherlands
Medicines Evaluation Board
Ireland
Irish Medicines Board
Italy
Italian Pharmaceutical Agency
Nigeria
National Agency for Food and Drug Administration and Control (NAFDAC)
Ukraine
Ministry of Health
Singapore
Centre for Pharmaceutical Administration Health Sciences Authority
Hong Kong
Department of Health: Pharmaceutical Services
Paraguay
Ministry of Health
Sweden
Medical Products Agency (MPA)
Thailand:
Ministry of Public Health
China
State Food and Drug Administration
Germany
Federal Institute for Drugs and  Medical Devices
Malaysia
National Pharmaceutical Control Bureau, Ministry of Health
Pakistan
Drugs Control Organization, Ministry of Health
South Africa
Medicines Control Council
Sri Lanka
SPC, Ministry of Health
Switzerland
Swissmedic  , Swiss Agency for Therapeutic Products
Uganda
Uganda National Council for Science and Technology (UNCST)
Brazil
Agencia Nacional de Vigiloncia Sanitaria (ANVISA )
Japan
Ministry of Health, Labour & Welfare(MHLW)
Costa Rica
Ministry of Health

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