The Priority Medicines (PRIME) scheme was launched in 2016 to enhance EMA support to the development of medicines that target an unmet medical need with the aim to help patients to benefit from these therapies as early as possible. This is achieved by optimizing the medicines development plans and speeding up their evaluation.
Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of medicines for early access. This document provides guidance, in a ‘toolbox approach’, by summarizing scientific elements and regulatory tools, available in the existing EU regulatory framework, that can be applied to support the development and completion of Module 3 quality data packages in the preparation of marketing authorization applications (MAA) of designated PRIME medicinal products.
This toolbox guidance follows on from the Workshop with stakeholders on support to quality development in early access approaches (i.e., PRIME, Breakthrough Therapies)1, held jointly with the US Food and Drug Administration (FDA). The consultation is open until 31 July 2021.
More information on the guidance and how to submit comments is available here: https://lnkd.in/gzTT__J