PCms that meet any of the following descriptions shall be regarded as "New medicines":
PCms in the "New medicines category" shall be registered under Group III only. For documents required for Group III registration, please refer to Table 2: Documents required for registration of pCm.
For technical requirement for various tests on safety, quality and efficacy of pCm, please refer to the relevant technical guidelines compiled by the Chinese Medicines Board. (Download).
Centres conducting the clinical trials for pCms must have met the requirements of "Good Clinical Practice for proprietary Chinese medicines" or other equivalent standards. Other clinical trial centres in China that are recognised both by the SFDA and the Chinese Medicines Board will also be accepted.
Applicants may obtain Application handbook for registration of proprietary Chinese medicines, the Application form, the Guide for Completion of Application Form and Checklist (3) in any the following ways:
Visit the Chinese Medicines Section of the Department of Health during office hours:
Address : 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon
Office Hours : Monday to Friday: 9:00 am to 5:30 pm
Saturday, Sunday & Public Holidays: Closed
Through facsimile request of the interactive information hotline (except Application Handbook)
Hotline number : 2574 9999
The completed Application Form and Checklist (3), together with all the required documents should be submitted :
Upon receipt of the application for registration, the Chinese Medicine Division of the Department of Health will carry out a preliminary check on the documents submitted. If the documents are sufficient and complete, the applicant will, within a short period of time, receive a confirmation receipt to confirm that the application is being processed. The confirmation receipt will include the file reference number allocated to that application.
For the required fees, please refer to Fees. Chinese Medicine Division will issue a General Demand Note to the applicant. The applicant could make payment according to the payment methods stated in the General Demand Note.
The application will be assessed by the Chinese Medicines Board. The applicant will be issued a "Certificate of registration of proprietary Chinese medicine" upon payment of the prescribed issue fee if his application is approved. The certificate is valid for 5 years.