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Table 1 Regulation about Chinese patent medicines from China in selected countries and regions

From: Internationalization of Traditional/Complementary Medicine products: market entry as medicine

Macau SAR Hong Kong SAR Singapore Australia Canada European countries US
The Netherland UK
Possible terminologies for CPMs from China in the country/region Chinese patent medicines Proprietary Chinese medicines Chinese proprietary medicines Complementary medicines (listed)
Complementary medicines (registered)
Natural Health Products Traditional herbal medicinal products Herbal medicine Botanical drug product
Definition “A product which has a definite pharmaceutical form and composes of (1) one or more ingredients from Part I and/or Part II of “List of Traditional Chinese Medicine Ingredients for consumption in Macao SAR”; or (2) one or more ingredients from Part III of “List of Traditional Chinese Medicine Ingredients for consumption in Macao SAR” and carry claims about treating, alleviating or preventing a disease or symptoms on the product label” “Refer to any proprietary products: (a) composed solely of the following as active ingredients: (i) any Chinese herbal medicines, (ii) any materials of herbal, animal or mineral origin customarily used by the Chinese; or (iii) any medicines and materials referred to in subparagraphs (i) and (ii) respectively; (b) formulated in a finished dosage form; and (c) known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body “Any medicinal product (a) which has been manufactured into a specific dosage forms and contains one or more active substances derived wholly from any plant, animal and/or mineral using active substances that are listed in the current edition of “A Dictionary of Chinese Pharmacy” or “The Chinese Herbal Medicine Materia Medica” “Therapeutic goods consisting wholly or principally of one or more designated active ingredients, each of which has a clearly established identity and (a) a traditional use or (b) any other use prescribed in the regulations” “Naturally occurring substances that are used to restore or maintain good health, often made from plants, but can also be made from animals, microorganisms and marine sources” “Also referred to as phyto-therapeutic products, medicinal products whose active ingredients contain exclusively plants, parts of plants or plant materials or combinations thereof, in crude or processed form; used for at least 30 years, including at least 15 years within the EU” “A product is a herbal medicine if the active ingredients are herbal substances and/or herbal preparations only” “A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans, which consists of vegetable materials (plant materials, algae, macroscopic fungi, or combinations thereof)”
Regulatory authority Department of Pharmaceutical Affairs, Health Bureau Chinese Medicine Council of Hong Kong (CMCHK)
Chinese Medicine Division of the Department of Health
Health Science Authority (HSA) Therapeutic Goods Administration (TGA) Health Canada (HC) Medicine Evaluation Board (MEB) Medicines and Healthcare products Regulatory Agency (MHRA) US Food & Drug Administration (FDA)
Major legal documents Decreta-Lei n 53/94/M
Decision No. 7/SS/2004
Technical Instruction No. 02/2005
Chinese Medicine Ordinance July 1999
Section 119—registration 3rd Dec 2010
Medicine Act Therapeutic Goods Act 1989 Natural Health Products Regulations of the Food and Drugs Act Traditional Herbal Medicinal Products Directive (2004/24/EC); the Dutch Medicines Act; and relative guidelines Directive 2004/24/EC for THR (Traditional Herbal Registration)
Directive 2001/83/EC for MA conventional)
Federal Food, Drug, and Cosmetic Act
Requirements to demonstrate quality Manufacturer’s license, GMP standards recommended but not mandated GMP standards and QC tests GMP standards
PIC/S guide
GMP standards
PIC/S guide and QC tests
GMP standards and QC tests GMP standards and QC tests GMP standards and QC tests GMP standards and QC tests
Requirements to demonstrate safety Drug Registration Certificate issued by the competent authority in the country of manufacture or country of origin
Limits of heavy metal content (Technical Instruction No. 2/2003)
Microbiological limits (Technical Instruction No. 1/2004)
Additional requirements for CPMs containing bovine-derived ingredients (Chief Executive Decision No. 120/2005 and Technical Instruction No. 02/2001)
Heavy metals and toxic elements test report, pesticide residues test report, microbial limit test report, acute toxicity test report, long-term toxicity test report, and the summary report on product safety documents Declaration on the absence of any poisons as defined in the Poisons Act (Cap. 234); Endorsement by manufacturer that product does not contain any Western drugs or active synthetic substances; TSE undertaking for products containing materials derived from ruminants; Information about for fermented substance for products containing fermented substance(s) Contains ingredients on the TGA’s list of permissible ingredients only for listed complementary medicines
Toxicological tests for registered complementary medicines
Conforming any of the monographs, “benefit to risk” assessment, additional evidence whenever needed Bibliographic review of safety data together with an expert report”; no need for safety test; clinical safety data (supportive) Bibliographic data for THR
Toxicological tests for MA
Non-clinical safety assessment: pharmacology/toxicology tests; clinical pharmacology trials
Requirements to demonstrate efficacy The materials of Interpretation and principle of formulating a prescription (excluding granules), reference materials on products efficacy and the summary report on product efficacy documents
Extra documents (principal pharmacodynamic studies report, general pharmacological studies, clinical trial protocol and summary report) maybe required
TCM system of therapeutics, historical records and traditional uses in pharmacopeias or with reference to A Dictionary of Chinese Pharmacy and The Chinese Herbal Medicine Materia Medic Traditional evidence and available efficacy data for listed complementary medicines
Clinical studies for registered complementary medicines
Attestation to a monograph for Class I category (low risk); monograph and additional information such as phase 2 clinical trials for Class II category (“medium risk”); high level of evidence from controlled clinical trials for Class III category (“high risk”) Justification of traditional use [long tradition of use for at least 30 years (including 15 years in the EU)]; bibliographical or expert evidence
Clinical studies for MA
Restricted indications and long tradition of use for at least 30 years (including 15 years in the EU) for THR
Clinical studies for MA
Individual studies/clinical trials