Abstract
Legal framework for pharmaceutical legislation in the European Union is complex but clear in its principles, with the main objective of safeguarding public health. The regulation of (traditional) herbal medicinal products is covered by regulations, directives and scientific guidelines to ensure safety and efficacy. Pharmaceutical quality criteria for herbal medicinal products is defined in the amended Directive 2001/83/EC and Directive 2003/63/EC and complemented with several scientific guidelines which ensure that all herbal medicinal products in the European market are manufactured or imported only by authorized manufacturers which have also followed the Good Manufacturing Practices adopted by the Community. This will lead to high quality herbal substances, herbal preparations and herbal medicinal products which can be placed in the market through different types of application: full application, well-established use or traditional use marketing authorization, according to the efficacy data. This article provides an updated review on the specific characteristics of these groups of medicinal products before they are granted a marketing authorization.
Highlights
The European Union (EU) regulatory framework for medicinal products is complex and is based on the need of a marketing authorization before placing medicines in the market
The EU regulatory framework includes specific requirements for herbal medicinal products (HMP) which are independent from their legal status: traditional herbal medicinal product (THMP) or products based on clinical evidence - well established use (WEU)
The full marketing application is chosen for new medicinal products and it has to be completed with the results of pharmaceutical tests, nonclinical studies and clinical trials
Summary
The European Union (EU) regulatory framework for medicinal products is complex and is based on the need of a marketing authorization before placing medicines in the market. The full marketing application is chosen for new medicinal products (new chemical entity) and it has to be completed with the results of pharmaceutical tests (quality documentation), nonclinical (toxicological and pharmacological) studies and clinical trials. Safety data have to be of sufficient size according the existing guidelines; efficacy is demonstrated by results from the clinical trials which have to be in conformity with the guidelines of the corresponding therapeutic area. This type of application is open for HMP, but only a few examples of herbal products have obtained a marketing authorization in the EU in this way
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