On May 19th, the website of the Drug Evaluation Center of the National Medical Products Administration released a notice on communication and exchange services related to the registration and registration of traditional oral Chinese patent medicines that have been listed in Hong Kong and Macao on the mainland. The full text is as follows.

Notice on Matters Related to Communication and Exchange Services for Registration and Registration of Traditional Oral Chinese Medicines Listed in Hong Kong, Macao and Mainland China

In order to effectively promote the process of listing and registration of traditional oral traditional Chinese patent medicines and simple preparations that has been listed in Hong Kong and Macao on the mainland, the applicant can propose communication or consultation as required from May 19, 2025, before the submission of the application for listing license of traditional oral traditional Chinese patent medicines and simple preparations that has been listed in Hong Kong and Macao on the mainland, upon the approval of the State Drug Administration. The specific requirements are hereby notified as follows:

1、 For communication and exchange situations that meet the requirements of the "Management Measures for Communication and Exchange in Drug Development and Technical Review", applicants can submit Class I meeting applications. The meeting materials submitted by the applicant shall comply with the requirements of Simplifying 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 on the Mainland. The Drug Evaluation and Inspection Dawan Branch Center (hereinafter referred to as the Drug Dawan Branch Center) shall organize the acceptance and review team to complete the communication and exchange review within 30 working days.

2、 For other situations that require communication and exchange, the applicant can consult through relevant pre - and in person communication channels of the Greater Bay Area Center for Drugs. The Greater Bay Area Center for Drugs will provide guidance and services according to the application path and time limit requirements.

National Medical Products Administration Drug Evaluation Center

National Medical Products Administration Drug Evaluation and Inspection Center of Greater Bay Area

May 19th, 2025