3. Legal bodies responsible for regulatory procedures
1. Legal bodies responsible for regulatory procedures
1.2. European Medicines Agency (EMA)
The European Medicines Agency (EMA), established in 1995:
- underpins the centralised authorisation procedure and supports coordination between NCAs. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities.
- is a decentralised agency of the European Union acting as a networking organisation based in Amsterdam, whose activities involve thousands of experts from across Europe. These experts carry out the work of EMA's scientific committees
- facilitates development and access to medicines
- performs the scientific evaluation of applications for marketing authorisation under the Centralised Procedure (CP).
- supervises and monitors the safety of medicines in the EU across their lifecycle
- provides information to healthcare professionals and patients and publishes clear and impartial information about medicines and their approved uses. This includes public versions of scientific assessment reports and summaries written in lay language.
- has seven scientific committees*, six of which concerned with human medicines, that perform its scientific assessments and evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.
- has in addition a number of working parties and related groups which the committees can consult on scientific issues relating to their particular field of expertise
EMA’s scientific committees:
It may be of interest to also know what is NOT in the remit of EMA. The box below (adapted from the EMA website) contains those items which EMA lists as not falling under their activities.
What EMA does not do