List of Stringent Regulatory Authorities (SRA)


The national drug regulatory authorities which are members or observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are considered as Stringent Regulatory Authority (SRA).


MEMBERS:

Founding Regulatory Members

1. European Union member States 

Austria, 

Belgium, 

Bulgaria, 

Cyprus, 

Czech

Republic, 

Denmark, 

Estonia, 

Finland, 

France, 

Germany, 

Greece, 

Hungary, 

Ireland,

Italy, 

Latvia, 

Lithuania,

Luxembourg, 

Malta, 

Poland, 

Portugal, 

Romania, 

Slovak Republic, 

Slovenia, 

Spain, 

Sweden, 

The Netherlands, and 

United Kingdom

2. Japan

3. United States


Standing Regulatory Members

1. Health Canada, Canada

2. Swissmedic, Switzerland


Regulatory Members

1. ANVISA, Brazil

2. COFEPRIS, Mexico

3. HSA, Singapore

4. MFDS, Republic of Korea

5. MHRA, UK

6. NMPA, China

7. SFDA, Saudi Arabia

8. TFDA, Chinese Taipei

9. TITCK, Turkey


OBSERVERS

Standing Observers

1. IFPMA

2. WHO


ASSOCIATES 

Through mutual recognition agreements:

1. Australia, 

2. Norway, 

3. Iceland, and

4. Liechtenstein 


This list may be updated from time to time.


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