Registration of Proprietary Chinese Medicines > Established medicines category

Except for Chinese medicine injections, pCm that is formulated according to any of the following prescription shall be regarded as "Established medicines":

  1. an ancient prescription (which has been documented in Chinese medicines bibliography in, or before, the Qing dynasty); or

  2. a modified ancient prescription (the prescription of which is based on an ancient prescription with reasonable and rational modifications) ; or

  3. a pharmacopoeia prescription (which has been documented in the Pharmacopoeia of the People's Republic of China); or

  4. any other prescriptions originated from the National Drug Standards of the People's Republic of China and accepted by the Chinese Medicines Board.

The original dose form of the prescription should not be changed, otherwise the pCm will be regarded as "New medicines category" (except for those ancient prescriptions provided that their principal manufacturing method remains unchanged).

The Chinese Medicines Board will adopt the following principles in deciding whether to accept a prescription originated from the National Drug Standards of the People's Republic of China as "Established medicines":-

  1. Accept only the latest promulgated standard of the prescription. For example, if a prescription is both documented in the Drug Standard of the Ministry of Health and the Pharmacopoeia of the People's Republic of China, the Chinese Medicines Board will only accept the one in current edition of the Pharmacopoeia.
  2. Consider the current use of the prescription. For example the Chinese Medicines Board will not accept the Drug Registration Standards that have been withdrawn due to safety concerns.
  3. The product specification of the pCm must fulfill the requirements imposed by the Chinese Medicines Board.

For documents required for various registration groups, 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).

 

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 (1), (2) & (3) 」 in any of the following ways:

  1. 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

  2. Through facsimile request of the interactive information hotline (except Application Handbook)
    Hotline number : 2574 9999

  3. Download from this homepage

 

How to submit the application

The completed Application Form and applicable checklist (Group I : Checklist (1) or Group II : Checklist (2) or Group III : Checklist (3)), together with all the required documents should be submitted :

  1. By mail to the Chinese Medicines Section 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 Medicines Section of the Department of Health during office hours.

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.

 

How to pay the application fees

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.

 

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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