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Enhancing the Quality and Efficacy of Generic Pharmaceuticals in an All-round Way

Consistency evaluation of quality and efficacy of generic drugs, which has attracted much attention from the pharmaceutical industry, has achieved phased results. The State Administration of Food and Drug Administration recently released the first batch of 17 generic drugs through imitation.

Catalogue of drug quality and efficacy consistency evaluation varieties and specifications. This marks a solid step forward in the process of comprehensively improving the quality and efficacy of generic drugs in China.

The core objective of the evaluation of the quality and efficacy consistency of generic drugs is to improve the quality of generic drugs in an all-round way and to realize the clinical substitution of domestic generic drugs for original drugs. It is of great significance to carry out the evaluation of the consistency of quality and efficacy of generic drugs for improving the overall level of the pharmaceutical industry, ensuring the safety and effectiveness of drugs, promoting the upgrading and restructuring of the pharmaceutical industry, and enhancing the international competitiveness. In August 2015, the State Council issued the Opinions on Reforming the Examination and Approval System of Pharmaceutical and Medical Devices. It regards 'Improving the quality of generic drugs, speeding up the consistency evaluation of the quality of generic drugs, and striving to complete the consistency evaluation of the quality of national essential drug oral preparations and reference preparations by 2018' as one of the five goals of reforming the system of examination and approval of pharmaceuticals. In February 2016, the State Council issued the Opinions on the Consistency Evaluation of Quality and Efficacy of Generic Pharmaceuticals, which marked the comprehensive opening of the conformity evaluation work. The opinions again clarify the target and time limit of evaluation, requiring that generic drugs approved for listing before the implementation of the new registered classification of chemicals should be evaluated consistently if they are not approved in accordance with the principle of consistency between the quality and efficacy of the original drugs. In the National Essential Medicines Catalogue (2012 edition), oral solid preparations of generic chemicals approved for sale before October 1, 2007 should be evaluated by the end of 2018. In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, reiterating once again the need to accelerate 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 approval system, gradually solved the problems of resource shortage and difficulty in obtaining reference preparations in clinical trial institutions of bioequivalence test (BE). It has done a solid job in selecting reference preparations, exempted the study of BE varieties in vivo, strengthened the work of review, verification and inspection, and accelerated the work of consistency evaluation. As of Jan. 2, 2018, there were 309 records of consistency evaluation BE, belonging to 182 items in the basic medicine catalogue, totaling 124 enterprises 73 varieties, 127 items out of the catalogue, totaling 77 varieties of 84 enterprises; 6028 records of reference preparations, including 3141 items in the basic medicine catalogue and 695 enterprises for the record.

Among the 13 varieties (17 specifications) that have passed the consistency evaluation, 4 varieties (4 specifications) are in 289 basic drug catalogues and 9 varieties (13 specifications) are in non-289 basic drug catalogues. The product specifications, enterprise research reports, bioequivalence test data and review information of the above varieties can be inquired through the information disclosure column of the General Administration Drug Examination Center.

In accordance with China's policy of encouraging and supporting the adoption of consistent evaluation of drugs, the General Administration of Follow-up will coordinate with relevant departments such as the National Health and Family Planning Commission to implement the issues of medical insurance payment, priority procurement, priority selection and so on. At the same time, the General Administration will also strengthen post-marketing supervision of varieties through consistency evaluation, intensify various kinds of inspection, especially flight inspection, promote strict and sustained compliance of pharmaceutical manufacturers, promote the continuous improvement of enterprise management level, and prevent consistency evaluation from turning into 'one-off' evaluation.