Health & Beauty

According to Huacheng Import and Export Data Observation, the State Drug Administration issued special regulations on the registration and administration of traditional Chinese medicine on the 10th, which will be implemented from July 1, 2023.

There are 82 special provisions in 11 chapters, which further refine the requirements related to the development of traditional Chinese medicine, strengthen the development and registration management of new drugs of traditional Chinese medicine, and promote the inheritance, innovation and development of traditional Chinese medicine.

The State Drug Administration said that "clinical - laboratory - clinical" is the main feature of the research and development of new drugs of traditional Chinese medicine. Therefore, it is specially stipulated to strengthen the development concepts such as "clinical value-oriented, human use experience, and whole-process quality control", organically combine the production process, quality standards, pharmacodynamics, toxicology, clinical research and other development contents of traditional Chinese medicine, and combine the basic requirements of drug safety, effectiveness, and quality controllability to establish a review and approval system that takes into account the basic requirements of drugs and has the characteristics of traditional Chinese medicine, Huacheng Import and Export Data Observation Report.

Special regulations encourage the use of emerging science and technology to study the mechanism of action of traditional Chinese medicine, learn from international advanced concepts, encourage the use of new biomarkers, alternative endpoint decisions, etc. for the evaluation of the efficacy of traditional Chinese medicine, and on this basis promote the development and innovation of new drugs of traditional Chinese medicine, Huacheng Import and Export Data Observation reported.

The special regulations fully attach importance to the support of "human experience" for the safety and effectiveness of traditional Chinese medicine, and set up a special chapter to clarify the specific connotation of human experience of traditional Chinese medicine, the compliance of evidence supporting the safety and effectiveness of traditional Chinese medicine, the requirements of pharmaceutical research, and the situation of human experience evidence supporting the registration application, which accelerated the establishment and improvement of evaluation methods and systems of traditional Chinese medicine. At the same time, it is also clear that the registration applicant can choose to directly start the clinical trial research from Phase I, Phase II or Phase III during the development according to the degree of support and different situations of the safety and effectiveness of traditional Chinese medicine based on the experience of human use. Huacheng Import and Export Data Observation Report.

The State Food and Drug Administration said that the special provisions are the deep integration of the drug registration management system and the characteristics and laws of traditional Chinese medicine, and the embodiment of the era and the specific practice of the inheritance and innovation of traditional Chinese medicine. It is specially stipulated to fully implement the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine, absorb the mature experience of the reform of the review and approval system of traditional Chinese medicine in recent years, combine the practical exploration of the transformation of the achievements of traditional Chinese medicine for epidemic prevention and control, draw on the scientific research achievements of drug supervision at home and abroad, build the registration and management system of traditional Chinese medicine in an all-round and systematic way, and promote the modernization of Chinese-style drug supervision, Huacheng Import and Export Data Observation Report.