EMA and FDA publish report on supporting developers in early access

The EMA and US FDA have published a report following a joint workshop on supporting medicine developers in early access approaches held in November 2018.

The aim of the workshop, hosted by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), was to discuss approaches to challenges companies face during the development of medicines under their respective early access programmes – the EMA’s PRIority MEdicines (PRIME) scheme and FDA’s Breakthrough Therapy designation.

In publishing the report, the EMA’s Head of Human Medicines Research and Development Support Division, Enrica Alteri said:

“With PRIME, we have established a platform that supports the development of promising medicines to help patients with unmet medical needs to benefit from these as early as possible

“Some challenges, for instance to complete quality and manufacturing development and data requirements are universal to early access programs. We have therefore teamed up with our partners at the FDA to organise this workshop and discuss together with pharmaceutical companies possible scientific and regulatory approaches that facilitate the preparation of robust quality data packages.”

According to information published by the EMA, since the launch of PRIME in 2016, the EMA has assessed 246 requests for eligibility, with 55 accepted on to the scheme.

Find out more about the EMA on MAP Online.

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Published 9. August 2019 in News, News UK