Studies to probe better pharmaceutical regulations
EMA and MIT announce research partnership
The European Medicines Agency (EMA) and the Massachusetts Institute of Technology (MIT) in the US have announced an innovative research partnership, which will probe the development of more effective pharmaceutical regulation.
The two bodies have agreed to investigate how rules can better support the efficient development of safe and effective drugs. In particular, they will examine how to incorporate better the views of patients in regulatory decision-making processes, taking into account their evaluations of medicines and their thoughts on the relative benefits and risks of taking certain medicines.
Research teams will also explore the potential for implementing ‘staggered and progressive approaches’ to issuing drug market approvals. And they will research improving the fulfilment of post-marketing regulatory requirements through reforming how these rules are framed and applied. This would be a ‘collaborative research project with a focus on enhancing regulatory science in pharmaceuticals’, EMA said.
MIT is channelling its part of the work through its Centre for International Studies (CIS) and Centre for Biomedical Innovation (CBI). The CBI will coordinate the work through its New Drug Development Paradigms (NEWDIGS) research programme. Project researchers will be looking at testing theories developed during these studies in practical demonstration projects. The aim is to complete all the work by December 2011.