Since 2014, there has been a welcome recognition within Europe of the need for improved regulatory mechanisms whereby medicines being developed to target serious or life-threatening diseases that represent an unmet clinical need can be made available to patients at the earliest opportunity.
This has resulted in the introduction of the Early Access to Medicines Scheme (EAMS) in April 2014, to support early patient access to important medicines in the UK, the first step of which is the MHRA’s Promising Innovative Medicine (PIM) designation within the EAMS. The EMA’s PRIority MEdicines (PRIME) scheme followed in March 2016, which provides additional regulatory support to the sponsor with the aim of optimising development plans with a view to accelerating the evaluation of important medicines across the EU.
This article by Kinesys Consulting Ltd. in TOPRA‘s Regulatory Rapporteur Journal presents the various programmes available to support expedited development of medicines in areas of unmet medical need, with particular focus on applications for PIM and PRIME designation. A procedural insight into each of these schemes is provided along with recent experiences of submitting consecutive PRIME and PIM applications relating to the same medicinal product, which was at the same stage of development and had an identical data package.
To access the article, click: here