This section of the website provides information for companies and individuals involved in developing and marketing medicines for human use in the European Union (EU).
For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU.
Overview
The European Medicines Agency (EMA) simplified the navigation of its regulatory section on human medicines in November 2016. This is intended to help users from pharmaceutical companies find information more efficiently.
Research and development
The European Medicines Agency (EMA) provides guidance and support to medicine developers. This includes scientific and regulatory information on how to design and run clinical trials, compliance standards, and obligations and incentives for developers of specialised medicines.
Marketing authorisation
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
Post-authorisation
The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle.
This sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.
Herbal medicinal products
The Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA). This gives companies and national competent authorities a clear reference point when preparing or assessing an application for marketing authorisation or registration of herbal medicinal products in European Union (EU) Member States.