First disclosure of CFDA: supporting reward and punishment measures for conformity evaluation of generic drugs

Source: e-medicine Facebook 2015-09-22 as a "very important, difficult to do, very time-consuming" work, the consistency evaluation method of generic drugs has received unanimous attention from the industry On September 18, Li Bo, Secretary of the Party group and vice president of CFDA, announced for the first time at the ASEAN drug cooperation and Development Summit Forum, CFDA's recent thinking on drug consistency evaluation and the next work plan The Chinese Academy of inspection is the legal institution and the highest technical arbitration institution of the state for the quality inspection of pharmaceutical biological products We believe that a series of rewards obtained through consistency evaluation in a series of published information are worthy of attention, but more attention should be paid to the punishment measures Because the former needs the cooperation of various ministries and departments and the combination of the actual situation, while the latter is relatively definite and clear "ban" Figure: Li Bo, vice president of CFDA and vice director of CFDA since November 2010 Party secretary of CFDA in March 2014 Target 1 Current stage (2015-2018): to complete the oral solid preparations of chemical generic drugs in the national essential drug catalogue approved before October 1, 2007 According to the statistics of the Chinese Academy of inspection, there are 300 varieties mentioned above, involving 17897 approval numbers and 1883 pharmaceutical manufacturers 2 In the future, if the quality and efficacy are inconsistent, the evaluation will be carried out in stages and batches It is expected to take 10-15 years Enterprises are encouraged to evaluate varieties outside the catalogue For the supplementary application of the enterprise to change the prescription and process, the General Administration shall set up a unified evaluation channel for evaluation The varieties that have passed the evaluation shall be publicized by the general administration to the society, clearly marked in the drug instructions and labels, allowing enterprises to apply for the pilot of drug listing license holders; the health and Family Planning Commission shall give priority to the use of drugs in bidding and purchasing; the Ministry of human resources and social security shall give priority to the inclusion in the medical insurance reimbursement catalogue; the Ministry of industry and information technology shall send support to the technical transformation of enterprises Disciplinary measures up to 2018, those varieties of chemical generic oral solid preparations in the national essential drug catalog that have not passed the evaluation shall not be listed Other varieties, which fail to pass the evaluation within three years after passing the evaluation, shall not be listed If the drug approval number fails to pass the evaluation at the expiration of the validity period, it shall be cancelled If more than three of the same varieties have passed the consistency evaluation, the varieties that have not passed the evaluation will not be used in bidding procurement, medical insurance reimbursement and other aspects Reference preparation and evaluation method the reference preparation has priority to the original product or internationally recognized drug of the same kind According to the requirements, the enterprise actively looks for the reference preparation and conducts research after filing; for the reference preparation that is difficult to be determined, it shall be determined by the General Administration after consulting the expert opinion; for the reference preparation that is not listed in China, the enterprise can apply for the one-time imported drug only for consistency evaluation Is it dissolution or be? It depends on the specific situation of the drug - each variety should carefully consider the evaluation method It is encouraged to use in vivo method for evaluation and, of course, in vitro method Why encourage in vitro? First of all, it should be based on scientific considerations According to BCS classification, class I can be exempted from be evaluation, and class IV can't pass the three-dimensional in vitro correlation; class II and class III drugs need specific analysis: if all be are made, the backlog will appear in clinical research institutions If the evaluation is completed according to the in vitro program, it is simple and economical; of course, the precondition is that the method is appropriate and the reference preparation is comprehensively compared to ensure pharmaceutical equivalence (key indicators such as magazines, raw material crystal shape, excipients, etc.) Three roles of Pharmaceutical Enterprises -- pharmaceutical supervision organizations that bear the main responsibility -- formulate evaluation standards and guiding principles, and local bureaus are responsible for supervising and spot checking the third-party organizations (industry associations and societies) -- build a communication bridge: assist in the selection of reference preparations, and organize the development of related research in the same variety of enterprises