Regulatory Authorities in Pharmacovigilance
A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety.
Regulatory Authorities play a vital role to meet the requirements of legal procedures related to drug development process in a country.
The regulatory body ensures compliances in various legal and regulatory aspects of a drug.
Regulatory authority and organizations are responsible in effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public.
Regulatory bodies provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
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| Regulatory Authorities in Pharmacovigilance |
List of Regulatory Authorities in Pharmacovigilance
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.
|
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 |
|
Costa Rica |
Ministry of Health |
|
New Zealand |
Medsafe – Medicines and Medical Devices Safety Authority |
|
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) |