Regulatory Members
- ANVISA, Brazil.
- HSA, Singapore.
- MFDS, Republic of Korea.
- NMPA, China.
- SFDA, Saudi Arabia.
- TFDA, Chinese Taipei.
- TITCK, Turkey.
- How many countries are in ICH?
- What are the 3 ICH regions?
- Which countries follow ICH GCP?
- Is India a member of ICH?
How many countries are in ICH?
ICH is now constituted by 16 Members and 28 Observers, after the ICH Assembly in 2018 approved TFDA, Chinese Taipei as a new Regulatory Member, and MMDA, Moldova, NPRA, Malaysia, NRA, Iran, SCDMTE, Armenia and TÄ°TCK, Turkey as new Observers.
What are the 3 ICH regions?
ICH was established through cooperation of the regulatory agencies and industrial parties of three main regions involved in pharmaceuticals: the European Union, the United States, and Japan.
Which countries follow ICH GCP?
This ICH GCP Guidance Integrated Addendum provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.
Is India a member of ICH?
India will soon become a full member of the International Council for Harmonisation (ICH), according to the country's Drug Controller General. ... ICH's founding members include the European Commission, the FDA and Japan's Pharmaceuticals and Medical Devices Agency.