EU-China Biopharmaceutical Innovation Roundtable

On 24 November 2022, the EU-China Biopharmaceutical Innovation Roundtable took place in a hybrid format connecting Brussels with Beijing.

This roundtable, organized by the European Chamber Pharmaceutical working group, the China Society for Drug Regulation (CSDR) and the European Federation of Pharmaceutical Industry and Associations (EFPIA), enabled an open dialogue on pro-innovation regulatory policies between representatives from the European Pharmaceutical Industry and government officials from the National Medical Products Administration (NMPA), led by Mr. Zhao Junning, Deputy Commissioner of the NMPA. 

Representatives from the European pharmaceutical industry, as well as representatives from the European Union Delegation to China, and the Embassies of Denmark, France and Germany participated in the roundtable.

In his keynote speech, Deputy Commissioner Zhao highlighted that Europe and China are committed to strengthening cooperation and dialogue on health and innovation, a bilateral cooperation priority highlighted at the 2022 EU-China Summit and the EU-China High-level Economic and Trade Dialogue.

The NMPA stated it will continue to deepen its participation in international regulatory cooperation, and to further enhance key regulatory policies, notably in relation to drug review and approval, global drug development, and drug risk management.

Following the key-note speeches, in-depth panel discussions on regulatory bottlenecks were held. Participants acknowledged China’s recent achievements through rapid regulatory reforms and discussed a number of solutions to minimize the duplication of clinical studies, enabling segmented cross-border manufacturing for biologics, and the implementation of ICHQ12 guidelines.

Delegates from the Danish, French and German Embassies in Beijing also actively contributed to the discussion, sharing best practices on bilateral initiatives, and supporting further collaborations in the future.

Building on the fruitful exchanges of the Roundtable, Mr. Olivier Charmeil, Chair of the International Committee of EFPIA, shared the commitment from the European pharma industry to improving our support and collaboration with China NMPA, so as to further:

  • China's inclusion in simultaneous global clinical programs and marketing authorisation submissions
  • China's engagement in the global pharmaceutical manufacturing and supply chains network
  • Continuous supply of medicines through the implementation of timely Chemistry Manufacturing Controls changes after the first marketing authorization.

This Roundtable, the first collaboration between NMPA, CSDR, EUCCC, and EFPIA, ended with a positive note. All parties appreciated the transparent and pragmatic exchange and expressed a strong desire for further cooperation in 2023.