EMA launches scheme to prioritise medicines access for patients
pharmafile | October 27, 2015 | News story | Manufacturing and Production | EMA, European Medicines Agency, medicines access
The EMA has launched a public consultation on a scheme which aims to enable access to more medicines.
The PRIME scheme aims to strengthen the support it offers pharma companies for medicines that have the potential to benefit patients who presently have no treatment options, or that may offer a major therapeutic advantage over existing treatments.
Through the scheme the EMA will offer “early and enhanced scientific and regulatory support to medicine developers to optimise the generation of robust data and enable accelerated assessment.” This will allow patients to benefit from therapies that may significantly improve their quality of life as early as possible, the Agency says.
PRIME builds on existing regulatory tools, particularly scientific advice and the accelerated assessment procedure which is used for medicines of major interest from a public health and therapeutic innovation perspective.
By providing enhanced support to medicines that address unmet medical needs, EMA will encourage developers to focus their resources on those candidate medicines that are likely to make a real difference to a patient’s life. PRIME also aims to strengthen clinical trial design so that patients participate in trials that are likely to provide the necessary data for an application for marketing authorisation, the Agency says.
The EMA will host kick-off meetings with a multidisciplinary group of experts from relevant EMA scientific committees and working parties to give preliminary guidance on the overall development plan and recommended regulatory pathway. To be granted a marketing authorisation in the European Union (EU), medicines that benefit from PRIME during their development will have to demonstrate that their benefits outweigh their risks, like any other medicine. The same evaluation standards will be applied to all medicines, whether they receive PRIME support or not.
EMA has published a reflection paper outlining the scheme. Pharma companies are able to comment until 23 December 2015.
Yasmita Kumar
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