First anniversary of PRIME – experience so far

22 March 2017

Registration opens for stakeholder meeting on 19 May 2017

The European Medicines Agency (EMA) is organising a meeting with its stakeholders to review the experience gained with its PRIME (PRIority Medicines) scheme one year after it was launched.

The aim 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.

The meeting will bring together medicine developers who have applied to PRIME as well patients, healthcare professionals, academics, industry representatives and health technology assessment (HTA) bodies. Representatives of EMA's scientific committees, which have a key role in the operation of the scheme, will present their perspective.

People interested in participating are invited to register by sending the registration form to [e-mail] by 21 April 2017. As the number of spaces is limited, EMA will allocate places per stakeholder group to allow attendance of a wide range of stakeholders. The event will also be broadcast live on the EMA website. Anyone can follow the broadcast by clicking on the 'multimedia' tab on the event page on the day of the event.

EMA launched PRIME in March 2016. The scheme provides early and enhanced support to medicines that have the potential to address patients' unmet needs.

PRIME helps developers of promising medicines optimise their development plans, collect robust data and submit high quality marketing authorisation applications, so these promising treatments can be authorised in a timely manner for the benefit of patients.

Once a candidate medicine has been selected for PRIME, the Agency:

• appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) for advanced therapies to provide continuous support and help to build knowledge about the medicine ahead of a marketing authorisation application;
• organises a kick-off meeting with a multidisciplinary group of experts across the Agency's committees, to provide guidance on the overall development plan and regulatory strategy;
• provides scientific advice at key development milestones, involving additional stakeholders as needed;
• offers a dedicated EMA contact point.

Medicines eligible for PRIME are also potentially eligible for accelerated assessment at the time of application for a marketing authorisation.

Since the launch of PRIME in March 2016, EMA has considered 82 applications for PRIME. The majority of requests (43) were submitted by SMEs. By 23 February 2017, EMA had granted PRIME status to 19 medicines (23%). Full one-year figures will be published at the time of the meeting.