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Article de Chinois | WPRIM | ID: wpr-873073

RÉSUMÉ

The necessity of establishing the review system in the administration of national drug standards was analyzed, in order to provide suggestions for improving the national drug standard work. The problems existed in national drug standard administration were analyzed and summarized, the purpose and significance of standard review system was analyzed, and the implementation of standard review system in other industries was reviewed. At present, there are some problems in the administration of national drug standards, such as imperfect working mechanism, unsatisfactory progress in the improvement of standards, low participation of manufacturers in the work of national standards, and unsmooth elimination mechanism of standards. The establishment of standard review system in national drug standard administration conforms to the objective law of standard management, which is helpful to improve the top-level design of national drug standard activities, solve the bottleneck problems in the durg standard work, realize the dynamic management of national drug standard, and promote the re-evaluation work of drugs after being put on the market. In a word, the establishment and implementation of the standard review system is conducive to the development of national drug standards.

2.
Zhongguo Zhong Yao Za Zhi ; (24): 2619-2622, 2017.
Article de Chinois | WPRIM | ID: wpr-258470

RÉSUMÉ

To improve the administration of local crude drug quality standard, the administration history, and current administration situation of local crude drugs were reviewed, the legal orientation and positive effect of local crude drugs were analyzed, and the existing problems were summarized. It was found that many problems existed in the administration of local crude drug quality standards, especially the phenomenon of homonym and synonym on their names. The suggestions on improving the administration of local crude drug quality standards were proposed. First of all, the construction of legal system should be strengthened to improve the administration methods. Secondly, the coordination mechanism should be developed to solve the outstanding problems. Thirdly, the basic research should be enhanced to resolve the general technical problems. Lastly, the channels to transfer the local crude drugs into pharmacopeia standards should be developed to achieve dynamic administration.

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