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Streamlined Approval Procedures Introduced for Traditional Chinese Medicine Compounds

Only non-clinical safety pharmacology studies now need to be submitted when registering a Traditional Chinese Medicine (TCM) compound. While there is no initial need to submit pharmacodynamic studies or clinical trial data, all post-launch adverse medical reactions must be reported to the relevant drug supervision authorities, together with details of any proposed risk control measures. All bundled information sheets should also be updated accordingly.

The new regulations, specified in the Administrative Provisions Regarding the Simplified Examination and Registration Approval of Traditional Chinese Medicine Compound Preparations Originating from Classical Prescriptions, were mandated by the China Drug Administration and came into effect on 1 June this year.

For further details (in Chinese), please visit the following link:

Announcement of the China Drug Administration on the Promulgation of Administrative Provisions Regarding the Simplified Examination and Registration Approval of Traditional Chinese Medicine Compound Preparations Originating from Classical Prescriptions (No. 27 [2018])

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