The National Medical Products Administration (NMPA) has issued the “Notification on Simplifying the Registration and Approval of Traditional Oral Traditional Chinese Patent Medicines Listed in Hong Kong and Macao in mainland China (draft proposal)”, and is soliciting public feedback until December 24, 2024. This move signifies a step towards streamlining the registration process for traditional Chinese medicines (TCMs) from these regions.
Scope and Requirements of the Draft Proposal
The draft proposal applies to traditional Chinese patent medicines manufactured by entities registered in Hong Kong and Macau, which have been approved for use in their respective regions for no less than 15 years and have manufacturing processes that comply with Good Manufacturing Practice (GMP) standards. Review bodies will conduct assessments based on existing technical requirements, with an expected completion timeline of 80 working days.
Responsibilities of Review and Administration Entities
The Greater Bay Area Center for Drug Evaluation and Inspection of NMPA will handle the review and evaluation of marketing approval, post-marketing changes, and re-registration applications related to these TCM varieties. The Chinese Pharmacopoeia Commission and the Center for Drug Reevaluation will be in charge of approving generic drug names, conducting suitability reviews for over-the-counter drugs, handling certification and delivery, as well as managing corresponding information construction. Additionally, the medical products administration of Guangdong will take on the responsibility for drug registration inspections.-Fineline Info & Tech
