Human Medicines

This area of the website provides access to all information produced by the European Medicines Agency (EMEA) relating to medicines for human use and their regulation.

The regulation of medicines is an important part of wider efforts in society to promote health and wellbeing. Medicines play a vital role in preventing, diagnosing and treating illness and disease. It is therefore important to ensure the availability of high-quality, safe and effective medicines.

In simple terms, the regulation of medicines involves deciding whether or not new medicines developed by the pharmaceutical industry are suitable to be placed on the market for use by patients, and whether they continue to be safe for use once they are on the market.

Regulation of medicines in the European Union

In the European Union (EU), a company that wishes to bring a medicine to the market may submit a single application to the EMEA for a 'marketing authorisation' (licence) that is valid simultaneously in all EU Member States, plus Iceland, Liechtenstein and Norway. This is called the 'centralised (or 'Community') authorisation procedure', and is mandatory for certain types of medicines and optional for others. (The precise scope is set out in Annex I of Regulation (EC) No 726/2004.)

Other authorisation procedures — 'national procedure', 'decentralised procedure' and 'mutual-recognition procedure' — exist for medicines that do not fall within the mandatory scope of the centralised procedure. An overview of these procedures is available here.

Role of the European Medicines Agency in the regulation of medicines

It is a fundamental requirement that decisions about the authorisation of medicines are based on an objective, scientific assessment of their quality, safety and efficacy.

Conducting these assessments is the primary role of the EMEA. Through its scientific committees, the EMEA assesses every medicine for which a marketing-authorisation application has been submitted (in accordance with the centralised procedure), and prepares a recommendation (called an 'opinion') that is then relayed to the European Commission, which has the ultimate responsibility for taking decisions on granting, refusing, revoking or suspending marketing authorisations.

Besides preparing scientific opinions on marketing-authorisation applications, the EMEA is also involved in:

• communicating authoritative and objective information about medicines to patients, healthcare professionals and other audiences
• promoting the availability of medicines
• continuously monitoring and assessing the safety of medicines on the market (a process known as 'pharmacovigilance')
• the designation of medicines for rare diseases ('orphan' medicines)
• providing special assistance to micro, small and medium-sized enterprises involved in the development of medicines
• assessing paediatric investigation plans (development plans) submitted in support of marketing-authorisation applications for medicines intended for use in children
• drafting regulatory and scientific guidance to assist companies in all areas relating to the development and marketing of medicines
• providing scientific advice and protocol assistance to companies seeking to submit applications to the EMEA
• providing scientific recommendations on matters relating to medicines referred to the Agency by EU Member States or by the European Commission ('referral procedures').

Further information

Use the menu on the left to access detailed information about the topics mentioned above.

For further information on EU legislation and procedures for the regulation of medicines, see also Volumes 1-4 and 9-10 of The Rules Governing Medicinal Products in the European Union.