(1998; 88 pages)
8.1 General considerations
8.1.1 Each country or area should adopt a regulatory system to manage the appropriate use of herbal medicines. Adopting a regulatory mechanism will help ensure that herbal medicines have acceptable quality, safety and efficacy. The WHO Guidelines for the assessment of herbal medicines should be consulted when assessment processes for herbal medicines are being prepared.
Legislation should act as clear guidelines to industry and in its formation should draw on the expertise of a wide range of stakeholders (industry, consumers, practitioners, etc).
Legislation on herbal medicines should also recognise specific issues such as traditional history of use and/or level of current (unregulated) usage in the community. As a general principle, the history of use of a substance should in most cases be adequate evidence of its basic safety, provided its proposed application appropriately reflects its historical use.
8.1.2 Characteristics of herbal medicines
Herbal medicines have several attributes which differ from chemical synthetic drugs.
Herbal medicines are major remedies used by traditional systems of medicine which were developed based on different concepts from those of modern medicine.
Herbal medicines, as defined above, are usually mixed chemical compounds. Often not all active components of herbal medicines have been isolated, characterized or quantified. Efficacy is a result of the summation of pharmacological activity of an undefined blend of active components from one or more species of herb. Even a single plant material is not a purified single chemical compound. Standard techniques for the control of individual purified components may not be applicable for evaluating the quality of herbal medicines. In most cases it may not be appropriate to transfer the existing controls on chemical drugs to herbal medicines.
Where herbal medicines are not prepared by traditional methods it would need to be established that the processes have not changed the safety and therapeutic activity of the herbal medicines.
8.1.3 The regulatory process is a mechanism for evaluating the safety, efficacy and quality of medicinal products. The levels of evaluation may vary depending on the product. A comprehensive regulatory system for pharmaceutical products would require adequate data on pharmaceutical chemistry, pharmacological and toxicological studies, clinical investigations and therapeutic applications. However, for herbal medicines some modifications to the regulatory system are necessary. The registration requirement for herbal medicines would most likely be different from that for purified chemical drugs.
8.1.4 Various assessment procedures can be established with consideration of the categories of herbal medicine and different country situations.
(a) Notification procedure (listing): This involves obtaining information on herbal medicines which are being sold in a certain country. The amount of information requested in a notification may vary. It may initially be restricted to the names of herbal medicines and of manufacturers or importers if the medicine is imported from other countries. It may then be expanded to require notification of the composition, the pharmacological action, and the therapeutic classification. The assessment of listed herbal medicines may focus solely on the safety and quality for each intended use.
The listed herbal medicines may include those used traditionally, which are well-established, and those only used for simple, self-limiting conditions, without therapeutic claims having been assessed.
(b) Registration procedure (licensing): This comprises detailed evaluation of data submitted in support of the safety, efficacy, and quality of pharmaceutical products. It also determines the indications for its use. The procedure includes an assessment of both the herbal medicinal product, manufacturing procedures and facilities.
8.1.5 All manufacturing procedures should be in accordance with Good Manufacturing Practices (GMP). However, for many developing countries, medicinal herbal products are manufactured by factories, small workshops or traditional medical practitioners which may not meet GMP requirements. Countries should establish a process for manufacturers to acquire GMP status within an established timeframe.
8.1.6 Different regulatory procedures may be applied to raw plant materials, processed plant materials and medicinal herbal products. In some countries, raw plant materials may not be required to be regulated.
8.1.7 For toxic plant materials, the regulatory authority may issue a list of controlled toxic plant materials to guide manufacturers, wholesalers or importers and the public. The use of listed toxic medicinal substances may need special regulations.
8.1.8 For countries where a mechanism for the regulation of herbal medicines has not yet been established, the regulation procedure could be initiated step by step. A first stage notification (listing) procedure will provide useful data on medicinal herbal products available on the market. Depending on human resource and laboratory facilities, more comprehensive regulatory procedures could be implemented in order to achieve an acceptable level of safety, quality and efficacy.