Herbal medicines – strengthening assessment methodology and improved communication for the public
"In a few years of existence, the European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC) has become a unique forum of scientific and regulatory expertise in the field of herbal medicinal products, traditional and not traditional, and it will continue to be the driving force of harmonisation," explains Werner Knöss, Chair of the HMPC.
In 2012, the HMPC adopted 15 Community herbal monographs (scientific opinions on herbal substances or preparations) and released seven monographs for public consultation. A total of 114 final monographs have been made available since the Committee was established in 2004. The monographs published to date cover a large number of therapeutic areas, with gastrointestinal disorders, urinary-tract and gynaecological disorders, and cough and cold being the most represented. The work plan for the HMPC for 2013 contains 30 draft or final monographs.
These figures represent a key achievement in the implementation of the European legislation for medicinal products containing herbal ingredients with a long tradition of use.
Herbal medicines are used by millions of people across Europe. The European directive that came into force in 2004 aims to protect public health by enabling the use of a reliable, unique set of information in the assessment of these products across the Member States and at the same time secure the free movement of herbal medicines within the European Union (EU). A Community herbal monograph comprises the HMPC’s scientific opinion on a given herbal substance and preparations thereof, based on the evaluation of all available scientific data and information on the historic use of these herbal ingredients in the EU vis-à-vis the requirements of the legislation. The information contained in such monographs is used by Member States to support the evaluation of marketing applications from companies.
Since 2004, the combined efforts of the HMPC and the Member States have enhanced the integration of many traditional herbal preparations within the large spectrum of medicines made available to European patients.
"The HMPC also contributes to harmonisation across the EU by providing guidance documents on evaluation of the quality, safety and efficacy of herbal medicines," explains Werner Knöss. In 2012, the Committee published, after public consultation, four guidance documents, either scientific or procedural, to support the assessment of quality and non-clinical safety data of herbal medicines. In total, 20 scientific guidelines and reflection papers have been published since 2004.
Standards, consistency and revised assessments
As part of the 2012-2015 work programme, which includes a range of important activities complementing those that form part of its regular assessment work, this year the HMPC will look into strengthening its assessment methodology, aiming for continued high quality standards for its new or revised assessments. The Committee will carry out a systematic review of adopted monographs, in particular looking at the consistency of assessments in those therapeutic areas where several monographs have been established during the last seven years. This makes full use of the experience and expertise gained over time by the HMPC and the Working Party on Community Monographs and Community List (MLWP) and the growing number of tools available, such as guidance on assessment criteria, sets of templates and a peer-review process (introduced in two stages in 2008 and 2010). The first monographs having undergone systematic review or revision will be published in 2013.
Improved communication for the public
The Agency has also started working on making the main information contained in the monographs as well as the studies and data used by the HMPC to issue its recommendations more accessible to the general public.
Patients’ and consumers organisations’ involved in the Agency’s activities have expressed strong support for this initiative, which will represent a valuable source of information on the European view on herbal medicines and add to the vast amount of information released by the different national regulatory authorities about the use of herbal medicines, resulting from their scientific work within the EU network of medicines agencies.