This guidance summarises scientific and regulatory approaches that developers of medicines supported by EMA’s PRIME scheme can use to generate robust quality data packages for an EU marketing authorisation application, to enable patients to benefit from these therapies as early as possible.

It aims to address common challenges with meeting quality and manufacturing development data requirements during development and at the time of marketing authorisation application.

It covers medicines containing chemicalbiological or biotechnologically derived substances and advanced therapy medicinal products (ATMPs).


The primary scope of this document is on medicinal products that have received PRIME designation by the CHMP2 and includes medicinal products containing chemical, biological and/or biotechnologically derived substances and Advanced Therapy Medicinal Products (ATMPs).


It is recognised that some of the tools described in this document may be considered, on a case by case basis, and subject to prior agreement with EMA, for certain products intended for early access that address an unmet medical need, but where PRIME status may not have been requested by the applicant. Therefore, applicants are recommended to liaise with EMA during their product development to confirm that the tools described in this document can be applied to their product. In this context, references to PRIME applications throughout this guideline may also apply to certain marketing authorisation applications targeting an unmet medical need.