Each
country has its own regulatory authority, which is responsible to enforce the
rules, regulations and issue the guidelines to regulate the drug development.
These different regulatory authorities are having different set of guidelines
to ensure the safety and efficacy of the manufactured drug which are
being supplied in respective country.
Sr. No. |
Regulatory Body |
Country |
Full Name |
1 |
CDSCO |
India |
Central
Drugs Standard Control Organization |
2 |
USFDA |
USA |
Food
and Drug Administration (FDA) |
3 |
TGA |
Australia |
Therapeutic
Goods Administration (TGA) |
4 |
MHRA |
UK |
Medicines
and Healthcare Products Regulatory Agency |
5 |
TPP |
Canada |
Therapeutic
Product Program |
6 |
EMEA |
Europe |
European
Medicines Agency |
7 |
DMA |
Denmark |
Danish
Medicines Agency |
8 |
MOH |
Costa
Rica |
Ministry
of Health |
9 |
Medsafe |
New
Zealand |
Medicines
and Medical Devices Safety Authority |
10 |
MPA |
Sweden |
Medical
Products Agency |
11 |
MEB |
Netherlands |
Medicines
Evaluation Board |
12 |
IMB |
Ireland |
Irish
Medicines Board |
13 |
IPA |
Italy |
Italian
Pharmaceutical Agency |
14 |
NAFDAC |
Nigeria |
National
Agency for Food and Drug Administration and Control |
15 |
MOH |
Ukraine |
Ministry
of Health |
16 |
HAS |
Singapore |
Centre
for Pharmaceutical Administration Health Sciences Authority |
17 |
Department
of Health |
Hong
Kong |
Pharmaceutical
Services |
18 |
MOP |
Paraguay |
Ministry
of Health |
19 |
MPH |
Thailand |
Ministry
of Public Health |
21 |
SFDA |
China |
State
Food and Drug Administration |
22 |
BfArM |
Germany |
Federal
Institute for Drugs and Medical Devices |
23 |
NPRA |
Malaysia |
National
Pharmaceutical Control Bureau,Ministry of Health |
24 |
MoH |
Sri
Lanka |
Ministry
of Health |
25 |
ANVISA |
Brazil |
Agencia
Nacional de Vigiloncia Sanitaria |
25 |
MHLW |
Japan |
Ministry
of Health, Labour & Welfare |
26 |
UNCST |
Uganda |
Uganda
National Council for Science and Technology |
27 |
AIFA |
Italy |
Italian
Pharmaceutical Agency |
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