ABSTRACT
In addition to requiring compliance with quality standards, the proposed traditional herbal medicinal products directive will require manufacturers of products to be registered under the scheme, to provide evidence of the safety of their products, and to comply with standard regulatory provisions on pharmacovigilance. There is a view that the criteria for efficacy and safety of complementary medicines should be the same as those for conventional drugs. Many complementary medicines, particularly herbal medicines, have a long history of traditional use. Some products, such as certain, standardized herbal extracts, have undergone extensive clinical investigation, and clinical trials involving the herbal medicines have been subject to systematic review/meta-analysis, including Cochrane reviews. However, because the composition of products varies between manufacturers, evidence of efficacy should be considered to be extract specific. Benefit–risk assessments for complementary medicines are difficult as information is lacking in several areas relevant to safety.
