Announcement of the State Drug Administration on matters relating to the evaluation of the quality and efficacy of generic drugs (No. 102 of 2018)
In recent years, all relevant departments have conscientiously implemented the "Opinions of the State Council on Reforming the Examination and Approval System for Pharmaceutical Medical Devices" (Guo Fa  No. 44) and the "Opinions of the General Office of the State Council on the Evaluation of the Quality and Efficacy of Generic Drugs" (Guo Ban Fa  No. 8) and other regulations, take effective measures to promote consistency evaluation; enterprises continue to increase investment in research and development, and actively carry out evaluation. In order to further improve the consistency evaluation work, with the consent of the State Council, the relevant matters are announced as follows:
1. Strict evaluation of standards and strengthening supervision after listing
Strict consistency evaluation review and approval work, adhere to the principle of review of the quality and efficacy of generic drugs and adhere to the standard, do not reduce the standard, and carry out technical review in accordance with the published guidelines for drug development technology. Strengthen the supervision and inspection of drugs after listing, and pass the drug for consistency evaluation into the next national drug sampling inspection plan, and increase supervision and inspection of relevant enterprises.
2, time obeys quality, reasonable adjustment of relevant work time limits and requirements
(1) The National Essential Drugs List (2018 Edition) has been implemented since November 1, 2018 and has established a dynamic adjustment mechanism to achieve linkage with the consistency evaluation. Varieties that have passed the consistency evaluation are prioritized in the catalogue, and varieties that have not passed the consistency assessment will be gradually transferred to the catalogue. For the varieties included in the national essential medicines list, the evaluation time limit requirements are no longer uniformly set.
(2) The generic drugs containing the basic drug varieties approved for listing before the implementation of the new chemical registration classification. After the first variety has passed the consistency evaluation, the same varieties of other pharmaceutical production enterprises should complete the consistency evaluation within three years. . If the company fails to complete the application within the time limit, if the enterprise considers it to be clinically necessary or has a shortage of market, it may submit an application for deferred evaluation to the local provincial drug regulatory authority. After the provincial drug regulatory department and the health administrative department have organized the research and approval, the enterprise may be appropriately postponed. . If it is not completed within the time limit, it will not be re-registered.
3, strengthen service guidance, and fully promote the consistency evaluation work
In-depth implementation of the State Council's "distribution service" reform requirements, adhere to the guidance, supervision and service are equally important, according to the specific conditions of the evaluation of varieties, separate treatment, separate measures, and further increase service guidance. Establish a green channel, and apply for consistency assessment on time to speed up the review process. If a company encounters major technical problems in the course of research, it may communicate with the drug evaluation agency in accordance with the relevant provisions of the “Administrative Measures on Communication and Technology Review Communication and Communication”. Further strengthen the guidance of key varieties and key enterprises, organize on-site research and communication, and help enterprises solve difficult problems.
4, strengthen supporting policies and mobilize the enthusiasm of enterprise evaluation
Give full play to the role of the market mechanism and stimulate the enthusiasm of enterprises to carry out consistent evaluation. Through the conformity evaluation of the varieties, the drug regulatory authorities allowed them to be marked on the instructions and labels, and included in the "China Listed Drugs Collection"; more than three drug manufacturers that passed the consistency evaluation of the same variety of drugs, In terms of centralized procurement of drugs, in principle, varieties that fail the consistency assessment are no longer selected. All localities should improve the centralized procurement policy on the basis of ensuring the quality and supply of drugs. The National Health and Health Commission supports the low-cost, clinically essential drugs in the National Essential Drugs List (2018 Edition) in supporting policies. Guarantee the demand for clinical medication.
State Food and Drug Administration
December 28, 2018