CFDA: strengthen the main responsibility of enterprises in conformity evaluation

Source: CFDA 2016-06-27 June 21-22, the State Food and Drug Administration held a meeting on the conformity assessment of quality and efficacy of generic drugs in Beijing, to implement the opinions of the State Council on the conformity assessment of quality and efficacy of generic drugs, and further promote the reform of drug review and approval system Director of the General Administration Bi Jingquan attended the meeting and made a speech The meeting pointed out that the consistency evaluation of quality and efficacy of generic drugs is an important measure to promote the supply side structural reform of pharmaceutical enterprises To improve the quality of generic drugs and to replace the original drugs in clinical practice is conducive to reducing the total cost of medicine, eliminating backward production capacity and improving the competitiveness of domestic generic drugs The meeting stressed that it is both a challenge and an opportunity to strengthen the main responsibility of the enterprise in the consistency evaluation Enterprises should choose the most reliable varieties, do a good job in basic research, select reference preparations, and carry out experiments as early as possible An enterprise has several varieties to complete the consistency evaluation, plus the implementation of the listing permit holder system, which can get the first chance in the competition According to the meeting, local food and drug regulatory authorities should attach great importance to consistency evaluation, strengthen leadership, improve working mechanism, and study and solve problems encountered in the work We should take the initiative to report to the Party committee and the government for the support of relevant departments The meeting was presided over by Wang Mingzhu, the deputy director, Li Wusi, the head of discipline inspection appointed by the CPC Central Commission for Discipline Inspection, and attended by Wu Zhen, Jiao Hong and sun Xianze, the deputy directors All departments and bureaus of the General Administration, all directly subordinate units, the main principals of food and drug regulatory agencies from 31 provinces (autonomous regions, municipalities directly under the central government), Xinjiang production and Construction Corps, and the relevant principals of the Health Bureau of the logistics support department of the Central Military Commission attended the meeting.