2021 China-EU regulatory dialogue on pharmaceuticals held

The China-EU working group on drugs held a conference via video link on May 11. Attendees included Xu Jinghe, Deputy Commissioner of China’s National Medical Products Administration (NMPA), Andrzej Jan RYS, Director of Directorate B: Health Systems, Medical Products and Innovation and DG for Health and Food Safety (DG SANTE) of the European Union (EU), and Emer Cooke, Executive Director of the European Medicines Agency (EMA).

At the conference, the two sides exchanged views on the standards and working procedures of registration inspection, research and actions on detecting impurities in active pharmaceutical ingredients (APIs), and shared experience on off-site inspections. Discussions were also held on API regulation cooperation, personnel exchanges and environmental risk assessment practices in drug licensing.

The China-EU working group on drugs was set up by drug regulatory authorities of China and the EU based on the consultation and cooperation mechanism between the two parties. Since its establishment in 2013, the two sides have been maintaining exchanges on laws, regulations and regulatory information, as well as on other issues of common concern through this mechanism.

At the conference, both sides expressed willingness to continue to further deepen collaboration in areas such as drug inspection, to jointly improve the quality of drugs and to make sustained efforts to meet people's health needs.

Other participants included officials from the NMPA and its affiliated institutions and representatives of the DG SANTE, the EMA and the EU Delegation to China.