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The ¡°4+7¡± collection and mining supervision work scheduling will release these

Copyfrom£º Release time£º2019-03-19 The editor£º

The “4+7” collection and mining supervision work scheduling will release these signals...
       Recently, the State Drug Administration held a “4+7” collection and procurement supervision work scheduling meeting to further implement the Party Central Committee and the State Council’s pilot work on centralized drug procurement and use, and research and deployment of drug evaluation through generic drug consistency, especially The “4+7” collection and supervision of the winning varieties will fully guarantee the quality and safety of the drugs. Chen Shifei, member of the party group and deputy director of the State Drug Administration, attended the meeting and delivered a speech.
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      The meeting pointed out that it is necessary to fully understand the importance of doing a good job in the "4+7" collection and winning the drug supervision work through the consistency evaluation. The centralized procurement and use of drugs is an important decision-making arrangement of the Party Central Committee and the State Council. It is a major measure to deepen medical reform and solve the problem of unsightly illness. The drug regulatory authorities must raise awareness, conscientiously implement the decision-making arrangements of the Party Central Committee and the State Council, and take the supervision of the "4+7" collection and winning varieties as an important task at present, and earnestly enhance the people's sense of access to safe drugs.
      The meeting emphasized that drug regulatory authorities at all levels should strengthen the supervision of the whole chain and the whole life cycle, strengthen the inspection of the GMP and GSP standards for the successful bidders, and strengthen the extension inspection of the raw and auxiliary materials for the winning bids. Local supervisors must firmly establish risk awareness, handle the relationship between service industry development and supervision, and strictly abide by the bottom line of quality and safety.
 
Meeting request
First, it is necessary to fully implement the main responsibility of the enterprise. The enterprise must strictly follow the standards and requirements adopted by the conformity evaluation to organize production, implement the quality responsibility of the whole life cycle, and effectively guarantee the quality and safety of the drug.
 
The second is to effectively implement the regulatory responsibilities, combine the actual supervision of the localities, refine the division of labor, implement the responsibilities, and earnestly do a good job in the bidding of varieties and the supervision of the production, circulation and use of the varieties through consistency assessment.
 
Third, we must actively cooperate with relevant departments to do a good job in supply security, actively support mergers and acquisitions, joint development, and ensure the supply of medicines and access to medicines for the people.
 
Fourth, it is necessary to use the “4+7” collection and supervision of the winning varieties as a starting point, and explore the establishment of long-term regulatory measures for the evaluation of varieties through consistency.
 
The relevant person in charge of the provincial drug supervision and administration department of the “4+7” collection and winning bidding enterprise, the drug registration department of the State Food and Drug Administration, the drug supervision department, the Chinese procuratorate, the drug examination center, the verification center, the evaluation center and other relevant units are responsible for People attend the meeting.