[official announcement] the 2018 deadline for conformity assessment is invalid, and there is no limit for the new base drug catalog

In recent years, all relevant departments have conscientiously implemented the opinions of the State Council on reforming the review and approval system of pharmaceutical and medical devices (GF [2015] No.44), the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (GBF [2016] No.8) and other provisions, and taken effective measures to promote the consistency evaluation; the enterprise continues to increase research Develop investment and actively carry out evaluation With the approval of the State Council, we hereby announce the following issues in order to further improve the consistency evaluation: 1 Strict evaluation standards and strengthened post Listing Supervision The review and approval of consistency evaluation shall be strictly carried out, the principle of consistency of quality and efficacy of generic drugs and original research drugs shall be adhered to, the standard shall not be lowered, and the technical review shall be carried out in accordance with the technical guidelines for drug research and development that have been issued We will strengthen post marketing supervision and inspection of drugs, incorporate drugs that have passed the consistency evaluation into the next year's national drug sampling plan, and intensify supervision and inspection of relevant enterprises 2、 Time subject to quality, reasonable adjustment of relevant working time limit and requirements (I) National Essential Drug Catalogue (2018 version) has been implemented since November 1, 2018 and a dynamic adjustment mechanism has been established to achieve linkage with consistency evaluation The varieties that have passed the consistency evaluation will be included in the catalog first, and the varieties that have not passed the consistency evaluation will be gradually transferred out of the catalog For the varieties included in the national essential drugs catalogue, there is no longer a unified time limit for evaluation （2） For generic drugs including basic drug varieties approved for marketing before the implementation of new registration and classification of chemical drugs, the consistency evaluation shall be completed within 3 years in principle for the same varieties of other drug manufacturers after the first varieties pass the consistency evaluation If the enterprise fails to complete the evaluation within the time limit, it may apply to the local provincial drug regulatory department for an extension of evaluation if it is deemed to be clinically necessary and in short supply in the market After the provincial drug regulatory department and the health administrative department organize the research and confirmation, the enterprise may extend the evaluation appropriately If it is not completed within the time limit, it shall not be registered again 3、 Strengthen service guidance, make every effort to promote the consistency evaluation work, thoroughly implement the reform requirements of the State Council for "releasing management service", adhere to the equal emphasis on guidance, supervision and service, according to the specific situation of the evaluation varieties, deal with the problems by classification and implement policies respectively, and further strengthen the service guidance Establish a green channel to review the application of conformity assessment as soon as it arrives, so as to speed up the review progress If an enterprise encounters major technical problems in the research process, it may communicate with the drug review institution in accordance with the relevant provisions of the administrative measures for communication and exchange of drug research and development and technical review Further strengthen the guidance for key varieties and enterprises, organize on-site investigation and communication, and help enterprises solve difficult problems 4、 Strengthen supporting policy support, mobilize the enthusiasm of enterprise evaluation, give full play to the role of market mechanism, and stimulate the enthusiasm of enterprises to carry out consistency evaluation The drug regulatory authorities allow the varieties passing the consistency evaluation to be marked on the instructions and labels, and include them in the catalogue of drugs listed in China; for more than three drug manufacturers passing the consistency evaluation of the same kind of drugs, in principle, the varieties failing to pass the consistency evaluation will not be used in the centralized purchase of drugs On the basis of ensuring the quality and supply of drugs, all localities should improve the centralized procurement policy based on the actual situation; the national health and Health Commission should support the low-cost and clinically necessary drugs in the national essential drugs catalogue (2018 version) in supporting policies to ensure the clinical drug demand It is hereby announced State Food and Drug Administration December 28, 2018