Registration of Proprietary Chinese Medicines > New medicines category

PCms that meet any of the following descriptions shall be regarded as "New medicines":

  1. its prescription comprises any one (or several) of the following:
    1. a newly discovered Chinese herb；
    2. a new medicinal part of a Chinese herb；
    3. an active group extracted from Chinese herb；
    4. a set of active groups extracted from a compound prescription;
  2. Chinese medicine injection；
  3. preparation of a new Chinese medicine prescription；
  4. pCm with altered route of administration；
  5. pCm with new indication；
  6. pCm with altered dose form.

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.

 

How to obtain application forms and other relevant information

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:

  1. Visit the Chinese Medicine Regulatory Office 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

  2. Download from this homepage

 

How to submit the application

The completed Application Form and Checklist (3), together with all the required documents should be submitted :

  1. By mail to the Chinese Medicine Regulatory Office of the Department of Health by registered post (the date of the post stamp will be taken as the submission date); or
  2. By hand to the Chinese Medicine Regulatory Office of the Department of Health during office hours.

Upon receipt of the application for registration, the Chinese Medicine Regulatory Office 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.

 

How to pay the application fees

For the required fees, please refer to Fees. Chinese Medicine Regulatory Office 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.

 

Application result

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.

 

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