What are the ICH countries?

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What are the ICH countries?

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?

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 TİTCK, Turkey as new Observers.

Is Switzerland part of ICH?

More participation from regulatory authorities all over the world is anticipated as they will be welcomed to be a part of counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members.

Is India an ICH country?

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.

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.

Is China an ICH country?

China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines.

Is the UK part of ICH?

The UK’s Medicines and Healthcare products Reg- ulatory Agency (MHRA) participates in the ICH as part of the EU’s delegation. As a Founding Regulatory Member, the EU, together with the other two Founding Regulatory Members (Japan and the US) has greater decision-making power within the ICH than any other ICH Members.

Who founded ICH?

The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.