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 Sanit
aria (ANVISA ) |
|
Japan
|
Ministry of Health, Labour & Welfare(MHLW)
|
|
Costa Rica
|
Ministry of Health
|
