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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 1,400 new medicines[1].
  • It supported investments: It has helped to attract the €35 billion that the pharmaceutical industry invest in European research and development every year[2]. Investments are needed to ensure continuous innovation of new treatments.
But more can be done, to keep pace with new ideas in science and technology, as well as to face unprecedented challenges. This has never been more evident than in the fight against COVID-19.

To deliver safe and high quality diagnostics, vaccines and treatments available to patients, as fast as possible, we have identified four areas for action within the existing legislative framework:
  1. Encourage the use of new types of clinical trials;
  2. Allow greater use of data from real world use;
  3. Allow ongoing dialogue and discussion about a treatment throughout development;
  4. Simplify how medicines and other healthcare products are regulated.

This is the Regulatory Road to Innovation.





[1] European Commission, Union Register of medicinal products for human use.
[2] EFPIA, The Pharmaceutical Industry in Figures, 2019