China will formulate and revise 3050 national drug standards and 500 medical device standards

Date of issue:2020-11-30 Number of views(

Improve drug quality, formulate and revise 3050 national drug standards and 500 medical device standards The State Council recently issued the 13th five year national drug safety plan, which pointed out that during the 13th Five Year Plan period, China will further improve drug quality, continuously improve relevant standards, gradually improve the review and approval system, and promote the construction of a healthy China.

During the "12th Five Year Plan" period, China's drug safety situation is stable and good, the public demand for drug use is further met, the regulatory standard system is constantly improved, and the whole process supervision system is basically formed. However, experts pointed out that the overall level of drug quality needs to be improved, some urgently needed clinical products are difficult to meet the actual needs of the public, and the problem of irrational drug use is prominent.

The quality and efficacy consistency evaluation of generic drugs is conducive to improving drug effectiveness, promoting supply side structural reform, and saving medical costs. The plan emphasizes that enterprises should be encouraged to carry out consistency evaluation, improve the working mechanism of consistency evaluation, enrich professional and technical forces, strictly standardize standards and procedures, and review the consistency evaluation materials and supplementary drug registration applications submitted by enterprises on time.

The reform of review and approval system is a powerful starting point to promote the development from a big pharmaceutical country to a powerful pharmaceutical country. The plan points out that it is necessary to improve the review and approval mechanism, strictly enforce relevant requirements, encourage R & D innovation, complete the pilot project of drug marketing license holder system, and encourage the R & D and marketing of new drugs and clinical generics with clinical value. Hu Yinglian, an associate professor of the National Academy of administration, believes that this reflects the plan's central goal of improving drug quality and integrating the strictest supervision into the best service.

Improving the system of regulations and standards is the infrastructure of drug quality and safety. The plan points out that during the 13th Five Year Plan period, 3050 national drug standards, 500 medical device standards and 30-50 inspection and detection methods for prohibited and restricted substances in cosmetics will be formulated and revised, and relevant technical standards and technical guidelines will be improved.

Only the most severe punishment and the most serious accountability can make the masses rest assured. The plan proposes to strengthen the supervision of the whole process of production, circulation and use, and seriously investigate and deal with illegal activities such as shoddy production and adulteration.

In order to improve the level of drug use specialization and guide the public to use drugs safely and rationally, the plan also specifies the goal of more than 4 licensed pharmacists per 10000 population. All the main managers of retail pharmacies have the qualification of licensed pharmacists and have licensed pharmacists to guide the rational use of drugs when they are in business.

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