The EMA have announced a stakeholder meeting to review the experience gained with its PRIME (PRIority MEdicines) scheme one year on. The meeting is to be held on 19th May 2017.
The PRIME scheme was launched in March 2016 and exists to provide early and enhanced support to medicines which have the potential to address unmet patient needs. As of 23 February 2017, 19 medicines have been granted access to PRIME. The scheme helps Sponsors to optimise their development plans, collect robust data and submit high quality marketing authorisation applications. Medicines which have been granted access to PRIME are also potentially eligible for accelerated assessment at the time of application for a marketing authorisation.
The stakeholder review meeting will bring together medicine developers who have applied to PRIME, patients, healthcare professionals, industry representatives, academics, health technology assessment bodies (HTA) and representatives of EMA’s scientific committees, which have a key role in the operation of the scheme. The purpose of the meeting is to:
- Receive feedback from users and potential users of the scheme
- Provide information on how the rules on eligibility have been applied and what types of support applicants have received so far;
- Discuss practical examples that illustrate the benefits of PRIME and how it builds on existing tools.
For the draft agenda click here. Interested parties are requested to register by 21st April 2017 by emailing a registration form to email@example.com. Places are limited so will be allocated by the EMA per stakeholder group to allow for a wide range of stakeholders to attend however the event will also be broadcast live on the EMA website.
Full details of the meeting can be found here.