New report on European regulation framework and innovation

Updated: Feb 11

Words by GOLD newsdesk

A new report from the EFPIA offers a comprehensive analysis of the EU regulatory framework with a view to help re-establish Europe as a world hub for medical innovation.


Aiming to support the European Commission’s review of the EU General Pharmaceutical legislation published in November 2020, ‘The Evidence MIX Report’ is based on 60 case studies of real-life regulatory hurdles. It highlights four priority areas for legislative change, namely reinforcing expertise-driven assessment and enabling a more agile centralised authorisation framework, enhancing expedited pathway frameworks supporting innovation, expanding the role of EMA in the assessment of drug-device/diagnostic combination products and replacing the paper patient information leaflets with electronic versions.

It is hoped that by focusing on these recommendations, the EU regulatory system will become more efficient, effective and globally competitive.


“The review of the general pharmaceutical legislation affords a once in a lifetime opportunity to deliver safer, better medicines to patients, faster,” said Nathalie Moll, Director General, EFPIA. “Any new regulatory framework must be globally competitive to stem the tide of cutting-edge technologies leaving Europe for the US, China and other regions. Only a regulatory framework that embraces a culture of excellence and of innovation will make Europe a true world-leader in life sciences and respond quickly to patient needs.”


A series of proposals will also be put forward by the EFPIA designed to deliver a steep change in rapid, more equitable access to medicines for patients, without compromising on safety, and ensure that Europe can be at the forefront of the development of the next generation of diagnostics, treatments and vaccines.