China introduces regulation to develop new TCM drugs

China on Friday released a regulation on the registration and administration of Traditional Chinese Medicine (TCM), in an effort to strengthen the development of new drugs, according to the country's top drug regulator.

The regulation, issued by the National Medical Products Administration, has further classified relevant requirements on research and development (R&D) of TCM, so as to better promote the inheritance and innovation of TCM.

Taking effect from July 1, the regulation noted that a review and approval system that emphasizes drug safety, efficacy, and quality while taking into account features of TCM will be established.

Researchers are encouraged to apply new science and technology to study the action mechanism of TCM, drawing upon advanced international concepts, said the regulation.

Applicants can start clinical trial research from Phase I, II, or III based on the safety and efficacy of the herbal medicine, which will largely stimulate R&D vitality, according to the regulation.

With a history of more than 2,000 years, TCM is seen by many as a national treasure in China for its unique theories and practices, and has thus received increasing attention and favorable policies from the government.

About 30 national TCM inheritance and innovation centers will be established by 2025. Such a move is to improve the country's capability in the basic study of Chinese medicine and the R&D of new herbal drugs.

China will strengthen the quality management of TCM and speed up the review and approval of new varieties in 2023, said Zhao Junning, deputy head of the administration.

The country will also make full use of TCM in its COVID-19 prevention and control in the new phase, Zhao added.

Over the past five years, a number of new TCM varieties with accurate therapeutic positioning and high clinical value have been approved to come into the market, effectively meeting the public demand for clinical treatment, the administration noted.

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