The work of evaluating the consistency of the quality and efficacy of generics, which has attracted much attention in the pharmaceutical industry, has achieved phased results. The State Food and Drug Administration recently released the first batch of 17 catalogues of varieties and specifications for evaluating the consistency of the quality and efficacy of generic drugs. 

This marks another solid step forward in the process of comprehensively improving the quality and efficacy of generic drugs in our country. 

The core goal of the evaluation of the consistency of the quality and efficacy of generic drugs is to comprehensively improve the quality of generic drugs and to realize the clinical substitution of domestic generic drugs for the original drugs. 

Carrying out the evaluation of the consistency of the quality and efficacy of generic drugs is of great significance to improve the overall level of China's pharmaceutical industry, ensure the safety and effectiveness of drugs, promote the upgrading and structural adjustment of the pharmaceutical industry, and enhance international competitiveness. 

In August 2015, the State Council issued the opinions on reforming the examination and approval system of Pharmaceutical and Medical Devices, which will "improve the quality of generic drugs and speed up the consistency evaluation of the quality of generic drugs. Strive to complete the national quality consistency evaluation of oral and reference preparations of essential medicines by the end of 2018" as one of the five major goals of reforming the drug review and approval system. 

In February 2016, the State Council issued the opinions on the consistency Evaluation of the quality and efficacy of generic drugs, marking the full start of the consistency evaluation work. 

The opinion once again defines the evaluation object and time limit, and requires that generic drugs approved for market before the implementation of the new registration classification of chemicals must be subject to consistency evaluation if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drugs. 

The oral solid preparations of chemical generic drugs approved before October 1, 2007 in the National essential drugs catalogue (2012 edition) should complete the consistency evaluation by the end of 2018. 

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the opinions on deepening the Reform of the examination and approval system to encourage Innovation in drugs and Medical Devices, reiterating the need to speed up the consistent evaluation of the quality and efficacy of generic drugs. 

In recent years, the General Administration has stepped up the reform of the drug evaluation and approval system, gradually solved the problems such as the shortage of resources in BE clinical trials and the difficulty in obtaining reference preparations, solidly selected reference preparations, exempted the study of BE varieties in vivo, strengthened the work of evaluation, verification and inspection, and accelerated the work of consistency evaluation. 

As of January 2, 2018, a total of 309 BE items were filed for consistency evaluation, belonging to 122items in the base drug catalogue, 73 varieties in 124 enterprises, 127items outside the catalogue, a total of 77 varieties in 84 enterprises, and 6028 items of reference preparations, of which 3141 items were in the base drug catalogue and 695 enterprises were registered. 

At present, among the 13 varieties (17 specifications) that have passed the consistency evaluation, there are 4 varieties (4 specifications) in 289 base drug catalogues and 9 varieties (13 specifications) in non-289 base drug catalogues. 

The product specifications, enterprise research reports, bioequivalence test data and evaluation information of the above varieties can be queried through the information disclosure column of the Drug Review Center of the General Administration. 

In accordance with China's policy of encouragement and support for drugs through consistent evaluation, the follow-up General Administration will coordinate the implementation of health insurance payment, priority procurement, priority selection and other issues involved in these varieties together with the National Health and Family Planning Commission and other relevant departments. 

At the same time, the General Administration will also strengthen post-market supervision of varieties that have passed consistency evaluation, strengthen various kinds of inspection, especially flight inspection, promote strict and continuous compliance of pharmaceutical manufacturing enterprises, promote the continuous improvement of enterprise management level, and strictly prevent conformance evaluation from becoming a "one-off" evaluation.