China

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The European Medicines Agency (EMA) supports the European Commission's acitivities in China, India and Russia, by contributing to interactions on pharmaceuticals between the European Union (EU) and the regulatory authorities of these countries.

The European Commission signed a 'consultation and cooperation mechanism' between the Directorate-General for Enterprise and Industry and the Chinese State Food and Drug Authority (SFDA) in 2007. 

This agreement includes specific interactions on pharmaceuticals and provides for annual meetings between the two parties. EMA participates in these meetings and any subsequent actions agreed.

EMA's acitvities focus on assisting China to implement similar good manufacturing practice (GMP) and good clinical practice (GCP) standards to those applied in the EU, in order to:

  • facilitate the use of products and data coming from China;
  • achieve a global approach to the manufacture and supervision of medicines in the long term.

Support to China includes:

  • inviting Chinese inspectors to participate as observers to any GMP and GCP inspection carried out by EU inspectors in China;
  • providing support to conferences and training in the context of the consultation and cooperation mechanism, where representatives from SFDA are involved.

For more information, see European Commission: Delegation to China.

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