Medical network - July 24 for implementing the law of the People's Republic of China law of traditional Chinese medicine (hereinafter referred to as the act of traditional Chinese medicine), the CFDA drafted "about the application of traditional process preparation traditional Chinese medicine preparations of medical institutions to implement the announcement of filing management (draft)" (hereinafter referred to as the "notice"), on July 21 in website hung, comment deadline is August 5.
Announcement, points out that the traditional craft of the document regulations make it is to point to by Chinese medicine yinpian after smashing or only extracted by water made of solid, semi-solid and liquid dosage forms, traditional granules and made from Chinese medicine yinpian after crushing the capsule, also including made with traditional method to extract wine agent, tincture.
Any of the following circumstances shall not be filed:
(1) the provisions of the administrative measures on the registration of pharmaceutical preparations (trial) shall not apply to the declaration of pharmaceutical preparations.
(2) different dosage forms with the same prescription as available in the market.
(3) Chinese medicine formula granules.
Other preparations not in conformity with the relevant provisions of the state.
Current registration management of traditional Chinese medicine medical organizations, mainly on the basis of the original issued by the state food and drug administration in 2005 in the preparation of medical institution "registration management measure (trial)" (hereinafter referred to as the "method") and the ministry of health in 2010, the state administration of traditional Chinese medicine, and the state food and drug administration jointly issued "on strengthening the management of the medical institutions of TCM opinion" (the traditional Chinese medicine medical administration [2010] no. 39).
According to the current regulatory thinking, some contents have been adjusted. One is from clinical trials, adjusting for clinical use in the annual report submitted materials, reason: has a long history of clinical use of such agents, if still follow the "method" regulation of test cases not less than 60 patients in clinical trials, the scientific nature and the necessity. 2 it is to some preparation from pharmacodynamics research, reason: the use of "method" regulation, the formulation in this medical institutions have at least 5 years (contain 5 years) using the history of traditional Chinese medicine preparation, may prevent the pharmacodynamics test data. Three is to strengthen the concept of source control, process control, mainly reflects in: need to submit the base of the original herbs and appraisal basis, data pretreatment, processing process, detailed process route, all process parameters, equipment and process research materials. |
