What is PRIME (priority medicines)?

PRIME (priority medicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. My previous blog introducing PRIME can be found here.

 

What is the update regarding PRIME?

The EMA published a report presenting results from the first five years of PRIME. Following the review a number of features are being implemented to further strengthen the scheme.

 

What new features are being implemented?
  • A roadmap for each PRIME development alongside a product development tracker will be established
  • Increasing flexibility of scientific advice – Expedited scientific advice can be provided specifically for PRIME developments in case of issues with a specific development programme that has already received comprehensive initial advice
  • Helping applicants better prepare for assessment – Submission readiness meetings will be held approximately one year ahead of the submission of a marketing authorisation application (MAA)

All the new features aim to facilitate and accelerate the generation of robust and relevant evidence for the evaluation of a MAA which will give patients earlier access to transformative treatments that can make a real difference.

 

If you would like to discuss how Fusion Pharma can support you with your PRIME application, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.

 

While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.