WHO Health Systems Library
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WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems
(2004; 82 pages)


Many people in the world today take herbal medicines or herbal products for their health care in different national health-care settings. Safety is a fundamental principle in the provision of herbal medicines for health care, and a critical component of quality control.

The objectives of these guidelines are to:

  • support Member States, in the context of the WHO International Drug Monitoring Programme, to strengthen national pharmacovigilance capacity in order to carry out effective safety monitoring of herbal medicines
  • provide technical guidance on the principles of good pharmacovigilance and the inclusion of herbal medicines in existing national drug safety monitoring systems; and where these systems are not in place, to facilitate the establishment of an inclusive national drug safety monitoring system
  • provide standard definitions of terms relating to pharmacovigilance, and safety monitoring of herbal medicines
  • promote and strengthen internationally coordinated information exchange on pharmacovigilance, and safety monitoring of herbal medicines among Member States
  • promote the safe and proper use of herbal medicines.

The guidelines were developed with the view that, within current pharmacovigilance systems, monitoring of the safety of medicines should be enhanced and broadened in ways that will allow the successful monitoring of herbal medicines. It is not the intention to suggest that different systems should be instituted for this purpose.

However, in view of the unique characteristics of the provision and use of herbal medicines, there are several technical issues that need to be addressed if adequate and effective monitoring is to be introduced. The guidelines therefore identify the particular challenges posed in monitoring the safety of herbal medicines effectively and propose approaches for overcoming them. Special attention is also given to the reporting system for adverse reactions to herbal medicines, and to the analysis of the causes of the reported adverse reactions.

Currently, the majority of adverse events related to the use of herbal products and herbal medicines that are reported are attributable either to poor product quality or to improper use. Member States are, therefore, encouraged to strengthen national regulation, registration and quality assurance and control of herbal medicines, as well as to give greater attention to consumer education and to qualified practice in the provision of herbal medicines.

Last updated: May 4, 2012