Herbal medicines 2004 – 2014
EMA celebrates ten years of harmonised standards across EU
Ten years since the introduction of the European legislation on herbal medicines, over 1,300 traditionally used herbal medicines have been registered, and more than 600 herbal medicines have been granted a marketing authorisation based on their well-established use in the EU Member States. These medicines are accompanied by clear and harmonised product information across the European Union, enabling citizens to make an informed choice when using herbal medicines for self-medication and healthcare professionals to base their prescription on comprehensive information on the medicines.
Herbal medicines are used by millions of people in Europe. The European Directive that came into force in 2004 aims to protect public health by enabling the use of a reliable and unique set of information in the assessment of herbal medicines across Member States.
During the evaluation of herbal medicines, Member States rely on scientific opinions on herbal substances, known as European Union monographs, provided by the European Medicines Agency's Committee on Herbal Medicinal Products (HMPC). These opinions contain information on the recommended therapeutic uses, any contraindications and interactions with other medicines and any potential undesirable effects. They are based on the review of all scientific data and information on the historic use of the herbal ingredients, including data on safety, efficacy and quality.
In addition to these scientific opinions, the HMPC has developed over 20 scientific guidelines that serve as common standards during the registration and authorisation of herbal medicines by Member States. They form a harmonised European backbone and a reliable reference for applicants when preparing national applications.
“In a few years of existence, the HMPC has become a unique forum of scientific and regulatory expertise in the field of herbal medicinal products", explains Werner Knöss, Chair of the HMPC. "The establishment of common standards for the licensing of herbal medicines across Europe has been essential to protect public health and allow citizens to trust the products they choose to use.”
Maintaining high standards and extending collaboration
The HMPC is now entering a new phase. Its initial focus on European phytotherapy containing a single ingredient will widen to include medicines containing a combination of herbal ingredients as well as non-European traditional medicines, such as Chinese medicines, used in Europe. This adds to the current work of the Committee of completing the assessment of the most important single herbal ingredients that were identified at the creation of the Committee. The list of almost 200 herbal substances was defined by the HMPC based on surveys and consultations and reflects the herbal ingredients most widely used by European citizens. In addition, the HMPC continuously maintains high quality standards for its existing opinions through systematic reviews and revisions based on available scientific data.
The Committee works closely with the European Directorate for Quality of Medicines and Healthcare as regards quality standards for herbal medicines. It aims to extend its collaboration with other European organisations to take into account the wide use of herbal products in different contexts, such as cosmetic products, medical devices and food supplements, in order to reach harmonised scientific opinions.
The HMPC is also strengthening collaboration with international regulators across the world. As for all medicines, herbal medicines face the challenges of globalisation. International cooperation in this area is not only essential to broaden the knowledge of medicinal plants, it should also in the long term lead to the establishment of a harmonised view on the assessment of herbal substances and ultimately to consistent, reliable and clear information for users of herbal medicines around the world.