What is the EU Drug Regulatory System?

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. These authorities work together to ensure that all medicines used in Europe are safe and effective. 
The European Commission plays an important role in the regulation of medicines in the EU. On the basis of scientific assessments carried out by EMA, it grants or refuses, amends or suspends marketing authorisations for medicines evaluated via the centralised procedure. It can also take EU-wide action when a safety issue has been identified for a nationally authorised product and when harmonised regulatory measures in all MSs are considered necessary following assessment by EMA’s safety committee, the PRAC. 
EMA is responsible for the scientific evaluation, primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU. EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation,supervision and pharmacovigilance of medicines.