Drug Discov Ther. 2024;18(4):210-212. (DOI: 10.5582/ddt.2024.01055)

Tailored to fit: China optimizes policies and regulations regarding drug registration and review to promote innovation in traditional Chinese medicine

Lu AR, Dou FZ, Qi FH, Gao JJ

The classification system for drug registration and the review and approval process influence the innovation and development of pharmaceuticals. China's previous classification standards for registration of traditional Chinese medicines (TCMs) overly emphasized the material basis while neglecting the clinical value of TCM. Moreover, the review and approval system did not fully consider the characteristics of new TCM drugs, such as the clinical experience already available for many TCM formulations guided by TCM theories. This resulted in suboptimal quality and quantity in the development of new TCM drugs. Since 2019, China has introduced a series of policies and regulations aimed at reforming the classification system for registration of TCMs and establishing a review system tailored to TCM characteristics. The new classification system for registration of TCMs emphasizes that the development of new TCM drugs should be oriented towards clinical value, focusing on meeting unmet clinical needs. The policies and regulations promote the conversion of prescriptions in ancient classics into new drugs and encourages the conversion of preparations from medical facilities into new TCM drugs. Secondary development of already marketed TCM products is encouraged to enhance the advantages of their clinical use. The new review system places importance on the role of TCM theories and clinical experience in supporting the registration of new TCM drugs. These reform measures have paved a path for registration and review of the characteristics of TCMs and will positively promote the development of new TCMs.

Full Text: