A report presenting the results from the first five years of the EMA PRIority Medicines (PRIME) scheme, has just been published.

EMA launched the PRIME scheme in March 2016 to support the development of medicines that are expected to benefit patients with no current treatment options for their disease or offer a major therapeutic advantage over existing treatments. Through PRIME, the EMA offers early and proactive scientific and regulatory support to medicine developers to optimise the generation of robust data on a medicine benefits and risks and enable accelerated assessment of medicines applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.

PRIME scheme has had a positive impact on the authorisation of new medicines that address patients’ unmet medical needs. The time to marketing authorisation was reduced for medicines that benefitted from PRIME support, giving patients earlier access to transformative treatments.

Enhanced interaction with regulators through PRIME is particularly useful for developers of more complex products and for applications that rely on smaller datasets. This includes Advanced Therapy Medicinal Products (ATMPs) and orphan diseases, which often present new scientific and regulatory challenges.

From March 2016 to June 2021, a total of 18 medicines that had PRIME support were approved in the European Union (EU). Among these, 10 received a conditional marketing authorisation enabling them to access the market earlier and reach patients more quickly; seven are ATMPs and 16 concern rare diseases.

The analysis also shows that the support to PRIME products throughout the development resulted in a reduction of the time required by the applicant to answer questions from EMA during the evaluation. Overall, this led to faster reviews and faster patient access to PRIME products.

A toolbox with guidance for developers of medicines supported by the PRIME scheme on quality data is currently being finalised, following a public consultation that took place last year. The guidance is intended to help developers to generate robust quality data packages for EU marketing authorisation applications, which will support the rapid assessment of promising medicines and enable patients to benefit from these therapies as early as possible.

Discover more by reading the full report here!


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