Chinese Medicine Regulatory Office

Publications & Guidelines

Table of Contents
Chinese Medicines Traders
# Description Printed
version
Barrier-free
version
Licensing of Chinese Medicine Traders
1. Handbook of the Application for Chinese Medicines Trader Licences Handbook of the Application for Chinese Medicines Trader Licences(rinted edition) Handbook of the Application for Chinese Medicines Trader Licences(Barrier-free version)
2. Guidance Notes on Application for Manufacturer Licence in Proprietary Chinese Medicines (External Packing) Guidance Notes on Application for Manufacturer Licence in Proprietary Chinese Medicines (External Packing)
Practising guidelines for Chinese medicines traders
1. Practising Guideline for Retailers of Chinese Herbal Medicines Practising Guideline for Retailers of Chinese Herbal Medicines(Printed edition) Practising Guideline for Retailers of Chinese Herbal Medicines(Barrier-free version)
2. Practising Guideline for Wholesalers of Chinese Herbal Medicines Practising Guideline for Wholesalers of Chinese Herbal Medicines(Printed edition) Practising Guideline for Wholesalers of Chinese Herbal Medicines(Barrier-free version)
3. Practising Guidelines for Wholesalers of Proprietary Chinese Medicines Practising Guidelines for Wholesalers of Proprietary Chinese Medicines(Printed edition) Practising Guidelines for Wholesalers of Proprietary Chinese Medicines(Barrier-free version)
Trade Show Licence
1. Licensing arrangements of Chinese herbal medicines tradeshow licence Licensing arrangements of Chinese herbal medicines tradeshow licence
List of Herbal Medicines Prohibited from Importation and Sale
1. List of Herbal Medicines Prohibited from Importation and Sale List of Herbal Medicines Prohibited from Importation and Sale
Exemption in accordance with section 158(1) by a person or institution concerned with education or scientific research) (Chinese Medicines Trader Licences)
1. Guidelines on application of exemption in relation to Chinese herbal medicines or manufacturer licence or wholesaler licence in proprietary Chinese medicines by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only) Guidelines on application of exemption in relation to Chinese herbal medicines or manufacturer licence or wholesaler licence in proprietary Chinese medicines by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)


Registration of proprietary Chinese medicines
# Description Printed
version
Barrier-free
version
Registration of proprietary Chinese medicines
1. Application Handbook for Registration of Proprietary Chinese Medicines Application Handbook for Registration of Proprietary Chinese Medicines (Printed version) Application Handbook for Registration of Proprietary Chinese Medicines(Barrier-free version)
2. Guidance Notes on How to Classify Products as proprietary Chinese medicines Guidance Notes on How to Classify Products as proprietary Chinese medicines
Application for Renewal of Registration of proprietary Chinese medicines
1. Flow Chart for Processing the Renewal of Registration of Proprietary Chinese Medicines (Chinese version only) Flow Chart for Processing the Renewal of Registration of Proprietary Chinese Medicines (Chinese version only)
Technical Guidelines for Registration of proprietary Chinese medicines
1. Technical Guidelines - Product Quality Documents Technical Guidelines - Product Quality Documents
2. Technical Guidelines - Product Quality Documents (Appendices) Technical Guidelines - Product Quality Documents (Appendices)
3. Technical Guidelines - Product Safety Documents Technical Guidelines - Product Safety Documents
4. Technical Guidelines - Product Safety Documents (Appendices) Technical Guidelines - Product Safety Documents (Appendices)
5. Technical Guidelines - Product Efficacy Documents Technical Guidelines - Product Efficacy Documents
6. Technical Guidelines - Product Efficacy Documents (Appendices) Technical Guidelines - Product Efficacy Documents (Appendices)
Good Clinical Practice for proprietary Chinese medicines
1. Good Clinical Practice for Proprietary Chinese Medicines (Translated copy*) Good Clinical Practice for Proprietary Chinese Medicines (Translated copy*)
Application for Certificate for Clinical Trial and Medicinal Test
1. Guidance Notes on the Application for Certificate for Clinical Trial and Medicinal Test (Translated copy*) Guidance Notes on the Application for Certificate for Clinical Trial and Medicinal Test (Translated copy*)
Labelling and package inserts of proprietary Chinese medicines
1. Guidelines on labels of proprietary Chinese medicines (Reference for the Trade) Guidelines on labels of proprietary Chinese medicines (Reference for the Trade)
2. Guidelines on package inserts of proprietary Chinese medicines (Reference for the Trade) Guidelines on package inserts of proprietary Chinese medicines (Reference for the Trade)
3. "Q&A for labelling and package inserts of proprietary Chinese medicines" (Chinese version only) "Q&A for labelling and package inserts
														of proprietary Chinese medicines" (Chinese
														version only) "
Exemption in accordance with section 158(1) by a person or institution concerned with education or scientific research) (Registration of proprietary Chinese medicines)
1. Guidelines on application of exemption in relation to proprietary Chinese medicine registration by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only) Guidelines on application of exemption in relation to proprietary Chinese medicine registration by a person or institution concerned with education or scientific research in accordance with section 158(1) of the Chinese Medicine Ordinance (Chinese version only)
Others
1. Guidelines on Variation of Packaging of Proprietary Chinese Medicines (Guidelines for the Trade) (Chinese version only) Guidelines on Variation of Packaging of Proprietary Chinese Medicines (Guidelines for the Trade) (Chinese version only)
2. Requirement of excipient used in pCm Requirement of excipient used in pCm
3. Information on Local Laboratories (For reference only) Information on Local Laboratories (For reference only)
4. List & relevant information of municipal Institutes for Drug Control in China that are recognized both by the Chinese Medicines Board and the China Food & Drug Administration (CFDA) (Chinese version only) List & relevant information of municipal Institutes for Drug Control in China that are recognized both by the Chinese Medicines Board and the China Food & Drug Administration (CFDA) (Chinese version only)
5. Guidelines for the Trade on Naming of proprietary Chinese medicines Guidelines for the Trade on Naming of proprietary Chinese medicines
6. Guidelines on the classification on the established medicines - ancient prescription and modified ancient prescription categories (Guidelines for the Trade) (Chinese version only) Guidelines on the classification on the established medicines - ancient prescription and modified ancient prescription categories (Guidelines for the Trade) (Chinese version only)
7. Guidelines on the classification on the non-established medicines - health-preserving medicines category (Guidelines for the Trade) (Chinese version only) Guidelines on the classification on the non-established medicines - health-preserving medicines category (Guidelines for the Trade) (Chinese version only)
8. Guidelines on the chemical compounds which could be regarded as materials of herbal, animal or mineral origin customarily used by the Chinese or artificial synthetic Chinese Medicines Substitute (Guidelines for the Trade) (Chinese version only) Guidelines on the chemical compounds which could be regarded as materials of herbal, animal or mineral origin customarily used by the Chinese or artificial synthetic Chinese Medicines Substitute (Guidelines for the Trade) (Chinese version only)
9. Guidelines on the pCm application for external preparations (Guidelines for the Trade) (Chinese version only) Guidelines on the pCm application for external preparations (Guidelines for the Trade) (Chinese version only)
10. Guidelines on the pCm application for the products contain "Cordyceps mycelium" or "other mycelium belongs to the Cordyceps genus" as the single active ingredient (Guidelines for the Trade) (Chinese version only) Guidelines on the pCm application for the products contain "Cordyceps mycelium" or "other mycelium
														belongs to the Cordyceps genus" as the single active ingredient (Guidelines for the Trade) (Chinese
														version only)
11. Guidelines on the pCm application for the products contain "Ganoderma spore", "Ganoderma spore oil" or "Ganoderma/Coriolus versicolor myceliym" (Guidelines for the Trade) (Chinese version only) Guidelines on the pCm application for the products contain "Ganoderma spore", "Ganoderma spore
														oil" or "Ganoderma/Coriolus versicolor myceliym" (Guidelines for the Trade) (Chinese version
														only)



Good Manufacturing Practice (GMP) in respect of proprietary Chinese medicines
# Description Related
link
Printed
version
Barrier-free
version
Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines
1. Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines
Guidelines for the Trade
1. "Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines" Qualification and Experience Requirements for Key Personnel (Guidelines for the Trade) "Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines" Qualification and Experience Requirements for Key Personnel (Guidelines for the Trade)
2. Documentation Requirements on Application for Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines) (Guidelines for the Trade) Documentation Requirements on Application for Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines) (Guidelines for the Trade)
Questions & Answers on Problems / Queries Commonly Encountered in Implementation of pCm GMP
1. Full Version (Chinese version only) Full Version (Chinese version only)
2. Personnel (Chinese version only) Personnel (Chinese version only)
3. Premise (Chinese version only) Premise (Chinese version only)
4. Equipment (Chinese version only) Equipment (Chinese version only)
5. Documentation (Chinese version only) Documentation (Chinese version only)
6. Manufacture (Chinese version only) Manufacture (Chinese version only)
7. Validation (Chinese version only) Validation (Chinese version only)
8. Quality Control (Chinese version only) Quality Control (Chinese version only)
9. Contract Manufacture and Test (Chinese version only) Contract Manufacture and Test (Chinese version only)
10. Complaints and Product Recalls (Chinese version only) Complaints and Product Recalls (Chinese version only)
11. Self-Inspection and Quality Audits (Chinese version only) Self-Inspection and Quality Audits (Chinese version only)
Chinese Medicines Traders Newsletters
1. Full version (Chinese version only)
2. Articles on GMP Topics (Chinese version only)
3. Intellectual Property Protection of Chinese Medicine (Dec 2014)(Chinese version only) Intellectual Property Protection of Chinese Medicine (Dec
													2014)(Chinese version only)
Pamphlet on GMP for Proprietary Chinese Medicines
1. Pamphlet on Good Manufacturing Practice (GMP) for Proprietary Chinese Medicines Pamphlet on Good Manufacturing Practice (GMP) for Proprietary Chinese Medicines
Practising Guidelines for Manufacturers of Proprietary Chinese Medicines
1. Practising Guidelines for Manufacturers of Proprietary Chinese Medicines Practising Guidelines for Manufactureres of Proprietary Chinese Medicines (Printed edition) Practising Guidelines for Manufactureres of Proprietary Chinese Medicines (Barrier-free version)
Recall Guidelines for Chinese Medicine Products
1. Recall Guidelines for Chinese Medicine Products Recall Guidelines for Chinese Medicine Products (Printed edition)
2. Supplementary guidelines on disposal of unserviceable/expired/recalled Chinese medicine products for Chinese medicines traders Supplementary guidelines on disposal of unserviceable/expired/recalled Chinese medicine products for Chinese medicines traders
If you want to download the application form for Certifcate for Manufacturer (GMP Certificate), please visit Forms and Guidelines.
For more information on GMP, please visit GMP for Proprietary Chinese Medicines Web Resources .

Government Chinese Medicines Testing Institute
# Description Printed
version
Barrier-free
version
1. Chinese Medicines Herbarium Chinese Medicines Herbarium
2. Webinar on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (Chinese Version Only) Webinar on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (Chinese Version Only)
3. Webinar on Identification of Easily Confused Species of Chinese Materia Medica (I) (Chinese Version Only) Webinar on Identification of Easily Confused Species of Chinese Materia Medica (I) (Chinese Version Only)
4. Webinar on Identification of Easily Confused Species of Chinese Materia Medica (II) (Chinese Version Only) Webinar on Identification of Easily Confused Species of Chinese Materia Medica (II) (Chinese Version Only)
5. Hong Kong Chinese Materia Medica Standards - Volume 10 Introduction and Latest Developments Hong Kong Chinese Materia Medica Standards - Volume 10 Introduction and Latest Developments
6. Applications of "Hong Kong Chinese Materia Medica Standards" Applications of "Hong Kong Chinese Materia Medica Standards"
7. Webinar on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (18 October 2021) Webinar on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (18 October 2021)
8. On-line sharing session on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (20 October 2021) On-line sharing session on “Identification of Easily Confused Species of Chinese Materia Medica in Hong Kong by Macroscopic and Microscopic Characteristics” (20 October 2021)


World Health Organization (WHO) Collaborating Centre
# Description Related link Printed
version
Barrier-free
version
1. World Health Organization Collaborating Centre for Traditional Medicine - Chinese Medicine Division, Department of Health, HKSARG World Health Organization Collaborating Centre for Traditional
													Medicine - Chinese Medicine Division, Department of Health, HKSARG World Health Organization Collaborating Centre for Traditional
													Medicine - Chinese Medicine Division, Department of Health, HKSARG (Barrier-free version)
2. The Regional Strategy for Traditional Medicine in the Western Pacific Region (2011-2020)
3. WHO Traditional Medicine Strategy 2014-2023
4. Other WHO publications in Traditional medicine