A regulatory system fit for the next generation of treatments
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. 

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 nearly 2,000 new medicines.
• It supported investments: It has helped to attract the €60 billion that the pharmaceutical industry invests in European research and development every year. Investments are needed to ensure continuous innovation of new treatments.

But medical innovations are becoming increasingly complex. From products that combine medicines with devices or diagnostics to cell and gene therapies, patients and health systems can look forward to better outcomes in a wide range of disease areas. At the same time, global competition is intensifying, and other regions are moving faster to attract life sciences investment.

An efficient and agile regulatory framework is essential for Europe’s competitiveness. To remain a leading location for developing and launching new medicines, Europe’s regulatory framework must evolve.

ONE Vision: from fragmentation to one integrated system

ONE Vision is EFPIA’s proposal for a connected and integrated EU regulatory system, bringing development, authorisation and lifecycle management together so that knowledge and evidence build progressively and carry forward.

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