The European Medicines Agency (EMA) announced on 7th October 2016 that it had agreed to the first steps in developing an electronic, multilingual database set to contain information about all human medicines authorised across Europe. The database will be available to both the public and to Healthcare Professionals. Initially, the database will include the product data currently provided to the EMA by medicine manufacturers during the regulatory process.
The 2010 pharmacovigilance legislation, which came into effect in 2012, gave the EMA the responsibility of launching a European medicines web portal for human medicines in collaboration with EU Member States and the European Commission. It also gave the Member States the obligation to launch similar national medicines web portals. These new legislative provisions set out a clear mandate for EMA and its partners to provide information online on medicines to the EU public, as a major part of their role in protecting public health. The legislation reads “The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal for the dissemination of information on medicinal products authorised in the Union.” (Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010, Article 26(1)).
The new database is to be welcomed because it will provide access to information on nationally and centrally authorised medicines for human use in the EU in a single repository. The information on nationally authorised products will be made available in a phased approach, initially via national web portal, then transitioning to data delivered through the EMA’s Data Integration Programme. This will increase the visibility of information on medicines held by the national competent authorities and the EMA.
The European medicines web portal is not only required by EU legislation, but also has the potential to bring benefits to EU citizens and the EU regulatory network. These benefits are:
• The availability of reliable information on medicines for patients and healthcare professionals
• That comprehensive pan-European information is in one place
• Enhanced cooperation and visibility within the EU regulatory network
• Improved data-sharing.
The information will also be of significant use to the regulatory affairs professional, in aiding the development of regulatory strategy and gathering supporting data for various types of regulatory applications including clinical trial applications (CTAs), orphan drug applications (ODAs) and marketing authorisation applications (MAAs).
At launch the level of data and functionality of the database will be limited but we should see this increase over time.
For more information on the database, please click here.