(1998; 88 pages)
8.4 Requirements for medicinal herbal products
For medicinal herbal products a notification (listing) or registration procedure should be used in most cases. The manufacturers, distributors or importers should provide information on items listed below in relation to the product. In general, the requirements for medicinal herbal products would be pertaining to the product, however, data on individual components may in some circumstances be required. Efforts should be made to achieve high standards of practice in this area wherever possible.
(1) For traditionally used medicinal herbal products the following are needed:
(a) name of the product;
(b) list of ingredient(s) (active and inactive) of the product with scientific name(s), part of the plant used, and quantity; and with reference to the source text for the prescription, if available;
(c) the list of plant ingredient(s) of the product with taxonomic classification, including species, genus, and family;
(d) methods and technology used in manufacture;
(e) physical and chemical identification tests;
(f) quality standards for the ingredients when necessary (which may include the limit of residue of heavy metals and pesticides, insecticide and herbicide);
(g) quality standards for the products;
(h) stability tests;
(i) therapeutic uses and dosage;
(j) evidence of traditional use or recent clinical experience with the product in the form proposed, to support the safety and efficacy of the product;
(k) package and packaging materials; and
(l) content on label or package insert.
For those traditionally used herbal medicines with new dosage forms or new administration routes, the following additional data may be needed:
(m) comparative data on bioavailability.
For special dosage forms, such as injections and nebulisers, additional data may be required.
For those traditionally used herbal medicines with new indications, the following data, additional to items (a) to (l) may be needed:
(n) reports on clinical trials.
(2) For new medicinal herbal products which contain herbs with no traditional history of use, the following data should be submitted, in addition to the data on items (a) to (l) listed above:
(a) data on pharmacodynamic, bioavailability tests, and general pharmacological studies;
(b) data on acute toxicity tests;
(c) data on long-term toxicity tests, if necessary;
(d) data on mutagenicity tests, if necessary;
(e) data on carcinogenicity tests, if necessary;
(f) data on reproductive and developmental toxicity tests, if necessary; and
(g) reports on clinical trials.
(3) For importing countries, confirmation of the regulatory status in the country of origin should be required. Countries should consider extending the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce to cover medicinal herbal products. Where countries and areas have not yet adopted this scheme, the importers should submit a certificate of free sale and certificates of Good Manufacturing Practice (GMP) for the country of origin. Those certificates should be issued by the drug regulatory authority of the country of origin. After reviewing all the documents, a registration or notification (listing) may be given to medicinal herbal products imported by individual importers and the registration or listing number must appear on the labels of medicine.