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The Regulatory Road to Innovation
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[1].
  • It supported investments: It has helped to attract the €41.5 billion that the pharmaceutical industry invests in European research and development every year[2]. Investments are needed to ensure continuous innovation of new treatments.
But with the revision of the EU pharmaceutical legislation, we are now in an important moment for Europe’s ambition to be a global leader in innovation.

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:


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[1] European Commission, Union Register of medicinal products for human use.
[2] EFPIA, The Pharmaceutical Industry in Figures, 2022
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