- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Regulation and Registration of Herbal Medicines
The legal situation regarding herbal preparations varies from country to country. In some, phytomedicines are well-established, whereas in others they are regarded as food and therapeutic claims are not allowed. Developing countries, however, often have a great number of traditionally used herbal medicines and much folk-knowledge about them, but have hardly any legislative criteria to establish these traditionally used herbal medicines as part of the drug legislation.
For the classification of herbal or traditional medicinal products, factors applied in regulatory systems include: description in a pharmacopoeia monograph, prescription status, claim of a therapeutic effect, scheduled or regulated ingredients or substances, or periods of use. Some countries draw a distinction between "officially approved" products and "officially recognized" products, by which the latter products can be marketed without scientific assessment by the authority .
The various legislative approaches for herbal medicines fall into one or other of the following categories :
- same regulatory requirements for all products;
- same regulatory requirements for all products, with certain types of evidence not required for herbal/traditional medicines;
- exemption from all regulatory requirements for herbal/traditional medicines;
- exemption from all regulatory requirements for herbal/traditional medicines concerning registration or marketing authorization;
- herbal/traditional medicines subject to all regulatory requirements; and
- herbal/traditional medicines subject to regulatory requirements concerning registration or marketing authorization.
Where herbal medicines and related products are neither registered nor controlled by regulatory bodies, a special licensing system is needed which would enable health authorities to screen the constituents, demand proof of quality before marketing, ensure correct and safe use, and also to oblige licence holders to report suspected adverse reactions within a post-marketing surveillance system .