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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