The 2018 China-EU Work Group Meeting on Drugs held in Hangzhou

On October 11-12, the 2018 China-EU Work Group Meeting on Drugs were held in Hangzhou, Zhejiang Province. Chen Shifei, Deputy Head of China Food and Drug Administration (CFDA) and Martin Seychell, Deputy Director-General of Health and Food Safety of EC attended the meeting. Officials from relevant departments of CFDA and Zhejiang Food and Drug Bureau and industrial representatives attended the meeting.

Chen Shifei said that in recent years, as the China-EU comprehensive strategic partnership develops, the bilateral cooperation is making further headway in different fields. In terms of drug regulation, the Chinese government attaches great importance to the exchanges and cooperation with the European Commission. The two sides signed the Dialogue and Consultation Mechanism, set up the work groups on drugs, medical instruments and cosmetics in succession, held meetings on a regular basis and carried out dialogue with industries to promote and deepen the implementation of various cooperation items.

Chen stressed that it is hoped that both sides can adhere to the scientific attitude to deepen the dialogue mechanism between regulators, substantively deepen mutual understanding and trust and resolve the mutual concerns through dialogues and consultation to launch effective regulatory cooperation and ensure the safety and availability in the drug use.

At the meeting, both sides exchanged views in terms of cooperation on ICH, PIC/S and personnel, regulation updates, drug review and approval system reform, regulation over clinical trial and active BPC, listened to the comments from industrial representatives and discussed about GMP examination, clinical trial and license for getting listed.

It was agreed upon that both sides should further strengthen the cooperation in the fields of international cooperation, personnel communication and information interconnection in regulatory legislation, etc. On the sideline, the EU delegation visited the Medical Port Town in Hangzhou and the modern drug hi-tech park in Shaoxing to keep abreast of China’s drug regulation system and industrial development.

(Source: CFDA Website)