On April 18, CDE released the Simplification of the Application Materials and Technical Requirements for the Registration and Approval of Traditional Oral traditional Chinese patent medicines and simple preparations Listed in Hong Kong and Macao on the Mainland, which came into effect from the date of release.

In order to implement the national strategic deployment of building the Guangdong Hong Kong Macao Greater Bay Area and the relevant requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), provide technical guidance for simplifying the listing and approval of traditional oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao, and support the development of traditional Chinese medicine in Hong Kong and Macao, according to the requirements of the Announcement of the State Food and Drug Administration on Simplifying the Listing and Approval of Traditional Oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao in Mainland (No. 7 in 2025), the Drug Approval Center has organized the formulation of the Application Materials and Technical Requirements for Simplifying the Listing and Approval of Traditional Oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao in Mainland (see the annex). According to the Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedure for Issuing Drug Technical Guidance Principles (Drug Administration Comprehensive Drug Administration [2020] No. 9), and with the review and approval of the National Medical Products Administration, it is now issued and shall come into effect from the date of issuance.

This is to inform you.

Annex: Simplify the application materials and technical requirements for the approval of the listing of traditional oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao

National Medical Products Administration Drug Review Center

April 18, 2025