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The pharmaceutical industry is expected to rebuild within 5 years. Domestic innovative drugs will usher in a dividend.

On January 19, the State Food and Drug Administration issued the "Guiding Opinions on Further Strengthening the Work of Food and Drug Standards",

On January 19, the State Food and Drug Administration issued the "Guiding Opinions on Further Strengthening the Work of Food and Drug Standards", and revised and revised 3,050 national drug standards to speed up the upgrading of drug standards and ensure the safety and effectiveness of drugs. This is another punch that the State Food and Drug Administration has made to improve the quality of Chinese medicines.


At present, one of the key tasks of the State Food and Drug Administration is the consistency evaluation. The so-called consistency evaluation refers to the level of quality and efficacy of generic drugs in line with the original drug, which was first proposed by the State Council in the National Drug Safety 12th Five-Year Plan in 2012. On March 5, 2016, the General Office of the State Council issued the Opinions on the Evaluation of the Consistency of Quality and Efficacy of Generic Drugs. The initial evaluation of the consistency was the oral tablets in 289 basic drug list varieties. On December 22, 2017, the State Food and Drug Administration publicly solicited the opinions on the technical requirements for the conformity evaluation of listed chemical generics (injection); More than 70% of Western medicines used in China are injectables. Compared with oral solid preparations, the coverage of injections is wider, the terminal amount is larger, and related enterprises are more. The impact on the industry exceeds the consistency evaluation of oral drugs. Next, the Chinese medicine injection will be evaluated for consistency.


In order to promote the work of conformity assessment, the State Council and its relevant competent authorities have issued corresponding policies. The core is two points: First, appropriate support is given to the payment of medical insurance through the conformity evaluation of drugs, and medical institutions should give priority to procurement and clinical The priority is to choose; the second is that the number of production enterprises that have passed the consistency evaluation of the same variety of drugs has reached more than three, and the varieties that have not passed the consistency evaluation are no longer selected in the centralized procurement of drugs. In the National Essential Drugs List (2012 edition), the chemical preparations for oral solid preparations approved before October 1, 2007 should be completed before the end of 2018, which requires clinical efficacy tests and varieties with special circumstances. The conformity assessment should be completed by the end of 2021; if it is not completed within the time limit, it will not be re-registered.