At EFPIA we are working to discover and develop innovative therapies, to deliver people the treatments they need, and eventually ensure a healthier future for European patients. Developing new medicines is a long, complex and risky process with no guarantee of success. It begins with the spark of an idea.
The regulatory framework is the process that allows to take this idea for a new treatment through clinical trials and tests to ensure it’s safe and effective, all the way through the final authorisation, before it can be made available to patients.
The European regulatory system has done great so far. For instance:
- It served patients: Since its foundation in 1995, the European Medicines Agency has recommended the authorisation of over 1,500 new medicines.
- It supported investments: It has helped to attract the €41.5 billion that the pharmaceutical industry invests in European research and development every year. Investments are needed to ensure continuous innovation of new treatments.
This revision is a chance to create an agile and streamlined regulatory framework, making Europe more competitive and bringing breakthroughs to patients faster.
Throughout the medicine's life cycle, we have identified 8 areas for immediate action and 4 areas requiring legislative change to accelerate pharmaceutical innovation in Europe:
Blog articles 05.10.22
Expedited regulatory pathways: A toolbox to provide innovative medicines to patients
For Europe to stand its ground amongst other international regulatory authorities, it is crucial to evolve and future-proof EU expedited regulatory pathways....Read Article
Blog articles 14.09.22
The future treatment of patients - Combination Products and Companion Diagnostics (Guest blog)
Regulatory Road to InnovationRead Article
Blog articles 23.06.22
Supply Chains reshaping - How to respond to a crisis
Blog articles 28.04.22
EU Regulatory Network - New Architecture for a New Era (Guest blog)
Imagine you built a house. It was not big, but sufficient for what you needed at the time. Over the years, your family grew, and that same house was not...Read Article
 European Commission, Union Register of medicinal products for human use.
 EFPIA, The Pharmaceutical Industry in Figures, 2022