Dialogue with Chinese authorities on medicine regulation

News 25/10/2019

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation. 

The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals. Topics for discussion between Guido Rasi, EMA's Executive Director, Andrzej Rys, Director responsible for Health Systems, Medical Products and Innovation at the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and Dr Shifei included good manufacturing practice (GMP) standards for active pharmaceutical ingredients, good clinical practice (GCP) standards, and the Commission’s strategic approach to pharmaceuticals in the environment. 

Discussions were also held around establishing a common training curriculum focused on GMP and GCP standards, in cooperation with other international partners and the World Health Organisation (WHO). In addition, EMA introduced the Chinese delegation to EMA’s role and activities in areas like inspection coordination, the evaluation and authorisation of medicines, and safety monitoring.

China is one of the main suppliers of active pharmaceutical ingredients to the EU and constitutes one of the world’s largest national pharmaceutical markets.

A joint EU-China consultation and cooperation mechanism was established in 2010 with the aim to promote information exchange and mutual understanding on pharmaceuticals, medical devices, cosmetics and regulatory science matters. Under this mechanism, the European Commission established the regulatory dialogue initiative to discuss issues related to pharmaceuticals with the NMPA.

EMA supports the Commission's activities in this dialogue with Chinese authorities by assisting China in the implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards, facilitating the use of medicines and data coming from China, and achieving a global approach to the manufacture and supervision of medicines in the long term.

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