European Medicines Agency

The European Medicines Agency (EMA) is an agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines. It works with national medicines authorities and expert committees to assess medicines for people and animals and to monitor their benefits and risks.

Scientific assessment and authorisation

EMA’s committees evaluate scientific data and make recommendations on medicines. In the centralised authorisation procedure, a company submits one application to EMA; the European Commission then takes the legally binding decision on marketing authorisation on the basis of the agency’s recommendation. Many medicines are assessed and authorised through national procedures.

EMA publishes scientific assessment reports and summaries written for patients and healthcare professionals. It also provides scientific guidelines and monitors medicine safety after authorisation. These are different kinds of information: an assessment explains an evaluation, while a public summary presents the main findings in accessible language.

The herbal medicines committee

The Committee on Herbal Medicinal Products (HMPC) is EMA’s committee for scientific information on herbal substances, preparations and combinations. It prepares opinions on their medicinal uses and safe conditions of use, EU herbal monographs and proposed entries for the EU list of substances and preparations for traditional herbal medicines. Its work helps national authorities use a common body of information when examining product applications.

A herbal monograph states the medicinal uses, intended population and safety information for the specified substance or preparation, including adverse effects and interactions. The accompanying assessment report reviews the supporting data. Preparations are assessed individually: an extract made with one solvent or by one process is not interchangeable with every other preparation of the same plant.

Traditional and well-established use

EU herbal monographs distinguish well-established use, supported by sufficient safety and efficacy data, from traditional use, accepted on sufficient safety data and plausible efficacy. Traditional-use registration can rely on documented long-standing use without clinical trials demonstrating efficacy. The two categories therefore describe different evidence bases.

A monograph is reference material for a product application, rather than a marketing authorisation for every product containing the plant. Member States take final monographs into account when assessing applications. EU list entries have a different legal status: the committee drafts them and the European Commission adopts the final entries, which are binding on applicants and national authorities.

EU herbal monographs concern medicinal use; European Pharmacopoeia monographs concern quality requirements for substances and preparations. Information about a specific herbal preparation is not an instruction for a dietary supplement containing the same plant. EMA does not evaluate food supplements or cosmetics and does not provide personal medical advice.