Evaluating the regulatory system
Improving the EU system for marketing authorization: learning from regulatory practice
A data–driven assessment of the regulatory system for marketing authorisation, based around a number of case studies, which aims to identify opportunities for improving the system. Specific cases include: pharmacovigilance & PASSs studies, the conditional marketing authorisation pathway, the decentralised & mutual recognition procedure and paediatric investigation plans.
The regulatory system for the marketing authorisation (MA) of medicines has been successful, helping to bring many safe and effective medicines to the market. Various changes to the system over recent years demonstrate the ambition of the EMA and its European network to learn and to adapt to new challenges.
Such changes to different parts of the regulatory system are directed at finding a better way to balance two main goals. First, to ensure timely patient access to medicines that address healthcare needs. Second, to ensure that medicines are marketed only when there is sufficient confidence about a positive benefit-risk balance.
Continuous reflection is therefore needed to assess whether or not regulation is achieving its intended aims, and many potential questions arise. For example, do we know the added value of recent changes? What can we learn from their introduction, and how can we make sure that future changes are implemented in an effective manner? Answering questions of this kind depends on gaining more insight into the use and performance of the regulatory system, via monitoring, analysis and evidence-based assessments. By producing the current report, Escher is seeking to make its own contribution to providing this insight.
Aims
The project has two aims:
- To provide a scientific analysis of topics in a number of key areas in the regulatory system
- To reflect on how the regulatory system can benefit from further research.
Organization and way of working
This is an independent research project carried out by Escher, under the umbrella of TI Pharma, and currently funded by a grant from EFPIA and AESGP. The project is executed by Utrecht University and Exon Consultancy. Additional public and private partners support the project by delivering data and expertise through advisory groups.
