Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications

On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.

The EMA launched the Priority Medicines (PRIME) scheme to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier.

This toolbox guidance summarizes scientific and regulatory approaches which can be considered and applied by Applicants, tailored to their product development in question, to facilitate the development and preparation of robust quality data packages. A well prepared and robust Module 3 will support timely access to the medicine for patients whilst providing assurance that product quality and efficacy and patient safety are not compromised. Similarly, applicants should ensure that manufacturers are compliant with EU GMP and are inspection ready at the time of submission.

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