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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