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NMPA issues two guidelines for TCM registration and evaluation

Updated: 2022-05-09

Under the arrangement of the National Medical Products Administration (NMPA), its Center for Drug Evaluation has formulated the Guideline for Clinical Research and Development of New Drugs of Traditional Chinese Medicine Compound Preparations Based on Human Use Experiences (Trial) and the Guideline for Communication Under the Evidence System for Registration and Evaluation Based on "Combination of Traditional Chinese Medicine Theory, Human Use Experiences and Clinical Trials" (Trial) in order to promote the construction of an evidence system for the registration and evaluation of traditional Chinese medicine.

Upon review and approval by the NMPA, the two guidelines were issued and came into force on April 29.