European scheme to develop drugs for diseases with no treatment launchedBMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i1385 (Published 08 March 2016) Cite this as: BMJ 2016;352:i1385
- Nigel Hawkes
The European Medicines Agency (EMA) has launched a scheme to speed up the development of new drugs that target diseases with no existing treatment.
Aimed at smaller companies and academic researchers, PRIME (PRIority MEdicines) aims to streamline the development process by offering early advice on clinical trial design. It said that much effort is wasted, especially by those less experienced in drug development, by poorly designed trials that do not address the issues needed for marketing authorisation.
Unlike the UK’s Early Access to Medicines scheme, PRIME does not shorten the authorisation procedure. Under the UK scheme drugs may be given market access if they show sufficient promise before a …