Objective: To study the present situation of chang after listing for record of traditional Chinese medicine formula granules (TCMFGs) by taking Shandong province as an example, so as to provide reference for the standardization and scientific regulation of the change. Methods: The relevant laws and regulations and the actual situation of the State and Shandong province on change after listing for record were analyzed, the problems existing in the changes were summarized, and reasonable suggestions on the requirements for chang after llisting for record data were puts forward. Results and Conclusion: After 30 years' development, the industry of TCMFGs made good achievements and encountered new problems. Based on the laws and regulations of change in TCMFGs and the record work practice of Shandong province, this article summarized and analyzed the problems existing in the change of enterprise name, quality standard, packaging materials, excipients/packaging materials manufacturers and production process. In order to ensure the quality of the change of TCMFGs, it is suggested that the supervisor should strengthen the policy guidance and technical guidance, and the enterprises should play the main responsibility and scientifically evaluate the necessity and rationality of the change, many measures should be taken to ensure the high-quality development of TCMFGs and provide reference for the scientific regulation of Chinese medicine.
Lu Xueming, Yang Yingying, Wang Chunfang, Zhao Lanting, Ma Lingling, Yin Ningning, Wu Haijun
. Present Situation and Suggestions on the Chang after Listing for Record of Traditional Chinese Medicine Formula Granules in Shandong Province[J]. Chinese Pharmaceutical Affairs, 2024
, 38(7)
: 757
-762
.
DOI: 10.16153/j.1002-7777.2024.07.005
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