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Special Provisions for TCM Registration released

CCFDIE| Updated: 2023-02-10

On Feb 10, the Special Provisions for Traditional Chinese Medicines Registration (hereinafter referred to as the Special Provisions) is issued by China NMPA and will take effect on July 1, 2023.

The Special Provisions consists of 11 chapters and 82 articles, including general provisions, registration classification and marketing approval of TCMs, rational application of empirical evidence for human use, innovative TCMs, modified new drugs of TCMs, compound preparations of TCMs originated from classic recipes, TCMs with identical name and identical recipes, post-marketing changes, registration standards, drug names and package inserts of TCMs, etc.

The Special Provisions is closely connected to the newly revised Drug Administration Law and Provisions for Drug Registration. Based on the general provisions for the regulation of drug registration, the relevant requirements for the R&D of TCMs are further refined, and the regulation of R&D and registration of innovative TCMs are strengthened.

The Special Provisions fully implements the guidelines of the CPC Central Committee and the State Council on promoting the preservation, innovation and development of TCMs, fully absorbs mature experience in the reform of the drug evaluation and approval system, combines with the practice and exploration of the transformation of TCM achievements in epidemic prevention and control, and learns from domestic and foreign scientific research in drug regulation, so as to establish a comprehensive regulatory system of TCM registration for vigorously promoting the development of drug regulation through a Chinese path to modernization.