Ethical and regulatory frameworks of clinical trials of herbal traditional medicines: A literature review

Abstract

Nowadays, the use of traditional medicine is more and more frequent in the world. Thus, in Africa, traditional herbal medicines whose quality, efficacy and safety are established by scientific methods including clinical trials, are considered a credible alternative.

This review aims to provide an update on the ethical and regulatory frameworks for clinical trials of traditional herbal medicines. It is based on searches in Scopus, Science Direct and Medline.

The data indicate that the existing ethical and regulatory frameworks are most often enacted in the form of recommendations in the world, which must be transcribed into sub-regional or national legislation to enjoy binding force. In West Africa in particular, there is no binding harmonized framework and the practice of clinical trials of traditional herbal medicines remains weak. However, for the sake of harmonization and immediate application of the legal framework for clinical trials of medicinal products for human use, Europe has opted for Regulations which are de facto binding on all Member States. In addition, European legislation promises traditional use experience as a measure of exemption from clinical trials for herbal medicines. In general, the regulatory process (approval, inspection, pharmacovigilance) is relatively the same for both conventional and traditional drugs.

The European experience of exemption from clinical trials for traditional herbal medicines could be capitalized on in African countries and regional blocks to promote a harmonized regulatory framework adapted to socio-cultural realities.