"4+7" centralized collection of the bid-winning varieties supervision work

Mar. 28, 2019

The State Food and Drug Administration convened the "4+7" centralized collection of the bid-winning varieties supervision work scheduling meeting deployment to strengthen the supervision of the varieties through consistency evaluation

Recently, the state drug administration held a "4 + 7" in the winning variety regulation work dispatch meetings, further implementation of the CPC central committee under the state council about drug centralized purchasing and using the pilot work deployment, the deployment by generics consistency evaluation of drugs, especially the "4 + 7" in the winning of varieties of supervision, to ensure the safety of drug quality. State drug administration party member, deputy director Chen Shifei attended the meeting and made a speech.

The meeting pointed out that it is important to fully understand the significance of "4+7" drug regulatory work to collect the winning varieties and pass the consistency evaluation. The pilot program for centralized drug procurement and use is an important decision and deployment of the CPC central committee and the state council. Drug regulatory authorities must raise awareness, conscientiously implement the decisions and arrangements of the CPC central committee and the state council, take the supervision of "4+7" collection of winning varieties as an important task at present, and effectively enhance the people's sense of safe use of drugs.

The meeting stressed that drug regulatory authorities at all levels should strengthen the supervision of the whole chain and life cycle, strengthen the inspection of the implementation of GMP, GSP and other specifications of the bid-winning enterprises, and strengthen  the extension inspection of the raw and auxiliary packaging materials of the bid-winning varieties. Local supervisors should firmly establish risk awareness, properly handle the relationship between service industry development and supervision, and strictly observe the bottom line of quality and safety.

 According to the requirements of the meeting, first, the main responsibility of enterprises should be fully implemented. Enterprises should organize production in strict accordance with the standards and requirements adopted in the consistency evaluation, implement the quality responsibility of the whole life cycle, and effectively guarantee the quality and safety of drugs. Second, we should earnestly implement the responsibility of supervision, combine with the actual supervision of local areas, refine the division of labor, implement the responsibility,  and do a good job in the production, circulation and use of the winning varieties and varieties through consistency evaluation. Third, we should actively cooperate with relevant departments in ensuring supply, actively support enterprise mergers, acquisitions and joint development, and ensure drug supply and access to medicines for the people. Fourth, we should take "4+7" collection winning variety supervision as the starting point, explore the establishment of consistent evaluation through the varieties of long-term supervision measures.

Relevant heads of the provincial drug regulatory departments where "4+7" winning varieties are collected, heads of the drug registration department, drug regulatory department, central people's procuratorate, drug examination center, inspection center, evaluation center and other relevant units of the state food and drug administration attended the meeting.

13th March, 2019