In today’s blog I will be taking a look at PRIME (priority medicines), a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need.
PRIME in a snapshot
1) PRIME focuses on medicines that address an unmet medical need; medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
2) A medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
3) EMA will provide early and enhanced support to optimise the development of eligible medicines, speed up their evaluation and contribute to timely patients’ access.
Benefits of PRIME for patients and medicinal product developers
- Aims to bring promising treatments to patients earlier, without compromising high evaluation standards and patient safety.
- Fosters early dialogue with EMA to facilitate robust data collection and high quality marketing authorisation applications.
- Scientific advice is provided at key development milestones whilst involving additional stakeholders such as health-technology-assessment bodies.
- Potential for accelerated assessment so that medicines can reach patients earlier.
- Guidance provided to help developers optimise development plans and regulatory strategy.
- Encourages developers to focus resources on medicines likely to make a real difference to patients’ lives.
How to apply for PRIME
1) Complete the electronic application form available on the PRIME website.
2) Include data – exploratory trial data showing clinical response efficacy and safety data in patients (prior to phase III/confirmatory clinical studies) to demonstrate that the medicine addresses an unmet medical need.
3) Submit via Eudralink to prime@ema.europa.eu (EMA responds after 40 days).
Are you a small and medium-sized enterprise (SME)?
While PRIME is open to all companies on the basis of preliminary clinical evidence, SMEs can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.
For detailed information on PRIME please refer to the EMA website.
If you would like to discuss how Fusion Pharma can support you with a PRIME application, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.