If you go to the EMA website and click “About us” you will read that “The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a market of over 500 million people living in the EU.”
No longer… on November 22, 2017 World Pharma News reported that “The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken by the EU 27 Member States in the margins of the General Affairs Council (Art. 50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.” Click here for the full story.
Don’t hesitate to contact PDG for help revising your European eCTD to FDA standards including ISS/ISE.