Here you can find links to resources related to safety regarding the use of herbal and traditional medicines. This includes guidelines, tools for correct nomenclature, videos, as well as links to external sites and resources.
We are continually updating this page so please check back often! If you have any tools, other resources or items of interest that you believe would be helpful for others and that you would like to share with members, please let us know, either as a blog, in one of the discussion groups, or email a site co-ordinator directly.
WHO
Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems
Theses guidelines were developed to guide exisiting pharmacovigilance systems, so that the monitoring of the safety of medicines should be enhanced and broadened in ways that will allow the successful monitoring of herbal medicines. The guidelines should be considered in conjunction with the publication entitled, 'Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre', which is reproduced as Part II of this publication.
Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues
This document is intended to work as a model for other regulations on the quality of medicinal plants, and should be a reference point for providers, and for political and administrative authorities that desire that phytotherapy be of help in promoting citizens’ health according to the safety and efficacy criteria.
Pharmacovigilance for Traditional Medicine Products: Why and How?
This briefing note is for policy-makers and traditional medicine practitioners. It introduces the concept of pharmacovigilance (PV), and explains its importance as part of monitoring the safety of traditional medicines. It is intended to help Member States to think about what to do about traditional medicine safety. It is prepared in question and answer format, and avoids lengthy technical explanations on pharmacovigilance
Research Guidelines For Evaluating the Safety and Efficacy of Herbal Medicines - Pub. 1993
WHO guideline on the research criteria for evaluating safety and efficacy of herbal medicines. Published following a 1992 meeting of the WHO Regional Office for the Western Pacific, these guidlines were prepared 'for research on different forms of herbal medicines, including those in traditional use. Basic scientific principles as well as any special requirements related to the use of herbal medicines in traditional practice have been incorporated in these guidlines.'
Uppsala Monitoring Centre
Pharmacovigilance of Herbal Medicines - Video
Souad Skalli, Assistant Professor of Ethnobotany at Mohammed V University of Rabat shares her knowledge about adverse drug reactions associated with herbal medicines and provides a comparison of the pharmacovigilance of herbal medicines to conventional drugs. Presentation handouts available.
The Importance of Scientific Plant Names in Herbal Pharmacovigilance - Video
From the Uppsala Pharmacovigilance training course 2016. Since his PhD at Natural History in London, Dr Bob Allkin has worked with computer scientists to manage information about plants Identification software, plant chemistry and plant use databases and as well as the University of Southampton and Kew, he has worked extensively in Latin America especially Mexico and Brazil. Here he discusses why plant names matter in herbal pharmacovigilance.
Navigating the Plant Names Jungle - Drug Safety Matters Podcast
An insightful podcast featuring Dr Bob Allkin, programe manager at the Royal Botanical Gardens, Kew, UK. In this interview, he describes some of the challenges associated with medicinal plant nomenclature.
The Herbal Anatomical Therapeutic Chemical Classification System (HATC)
The Herbal ATC system (HATC) provides a scientific framework for the nomenclature and therapeutic classification of herbal substances and their combinations. The system is used as an integrated part of WHODrug Global to classify products and substances amd facilitates capture, grouping and aggregation of herbal remedies data at different levels of specificity.
The Herbal ATC system is provided via a subscription to WHODrug Global and the Herbal ATC codes are available only as integrated part of the WHODrug Global dictionary structure.
International Society of Pharmacovigilance (ISoP)
Herbal and Traditional Medicines Special Interest Group
This special interest group (SIG) was launched in 2017 and explores issues relating to the safety and pharmacovigilance of herbal and traditional medicines. The SIG aims to provide a platform for ISoP members interested in herbal and traditional medicines to share and provide information on relevant issues and developments, and to support and promote progress in the pharmacovigilance for herbal and traditional medicines and other natural health products.
European Medicines Agency (EMA)
Herbal Medicinal Products: Scientific Guidelines
The EMA provides a number of guidelines related to the quality and safety of herbal medicinal products.
The International Plant Names Index
The International Plant Names Index (IPNI) is a collaboration between The Royal Botanic Gardens, Kew, The Harvard University Herbaria, and The Australian National Herbarium, hosted by the Royal Botanic Gardens, Kew. IPNI provides nomenclatural information (spelling, author, types and first place and date of publication) for the scientific names of Vascular Plants from Family down to infraspecific ranks.
Herbal Medicines Compendium
The Herbal Medicines Compendium (HMC) is a freely available online resource that provides standards for herbal ingredients used in herbal medicines. In addition, the HMC provides notifications on the safety of herbal medicines and nomenclature guidelines.
Australian Government Department of Health
Pharmacovigilance and Complementary Medicines - Regulatory Requirements - Presentation
This presentation by Dr Claire Larter from Therapeutic Goods Administration details regulatory requirements for the pharmacovigilance of complementary medicines. This includes how the risk-benefit ratio is assessed and how adverse events are monitored and reported.
Guidance on Equivalence of Herbal Extracts in Complementary Medicines
This guidance document describes the circumstances under which a herbal extract may be considered to be 'equivalent' to an ingredient currently included in a therapeutic good, and which therefore may be used as a substitute for the ingredient, without the product being considered to be a separate and distinct good.