PRIME: priority medicines

PRIME is a scheme launched by the European Medicines Agency (EMA) 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 optimise development plans and speed up evaluation so these medicines can reach patients earlier.

Through PRIME, the Agency offers early and proactive support to medicine developers to optimise the generation of robust data on a medicine's benefits and risks and enable accelerated assessment of medicines applications.

This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.

Accelerated assessment

PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. This means that developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.

Fostering early dialogue

By engaging with medicine developers early on, PRIME is aimed at improving clinical trial designs so that the data generated is suitable for evaluating a marketing-authorisation application.

Early dialogue and scientific advice also ensure that patients only participate in trials designed to provide the data necessary for an application, making the best use of limited resources.

Key benefits for applicants

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

  • appoint a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy to provide continuous support and help to build knowledge ahead of a marketing-authorisation application;
  • organise a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts, so that they provide guidance on the overall development plan and regulatory strategy;
  • assign a dedicated contact point;
  • provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;
  • confirm potential for accelerated assessment at the time of an application for marketing authorisation.

Eligibility criteria

The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA.

To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.

5 year review (2016-2021)

EMA's 5-year report on the PRIME scheme provides a detailed analysis and review of the Agency's experience with the scheme in its first 5 years of application. 

It looks at how the scheme helped developers prepare for marketing authorisation assessments, comparing PRIME products to equivalent non-PRIME products.

The report shows that the PRIME scheme can help speed up patient access to new medicines that target an unmet medical need.

It also calls for further improvements, including consideration to the best timepoint for applicants to enter the PRIME scheme, and in helping them be better prepared for the marketing authorisation assessment phase.

The report covers data collected between March 2016 and June 2021.

Related information materials

Visual guide: 5-year report highlights
PRIME: 5 years experience

Key figures

The charts below provide key figures on PRIME eligibility requests.

They show the cumulative recommendations up to the latest CHMP meeting.

Recommendations adopted by 21 July 2022.

Applications and eligibility decisions

PRIME figures July 2022

* Out of scope applications are not included in the breakdown by type of applicants or therapeutic areas

Type of applications

PRIME applications July 2022

Therapeutic areas

PRIME therapeutic area July 2022

List of products granted eligibility

EMA updates the list of all products granted access to the PRIME scheme below on a monthly basis. EMA removes products from the list if they receive a marketing authorisation application for them, if they are withdrawn from the scheme or no longer meet the eligibility criteria.

The information is also contained in the annexes of the monthly CHMP highlights.

Earlier support for small businesses and researchers

While PRIME is open to all companies on the basis of preliminary clinical evidence, applicants from the academic sector and micro-, small- and medium-sized enterprises (SMEs) can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.

SMEs and academia generally have less experience with the regulatory framework and therefore would benefit from earlier scientific and regulatory advice.

They may also request fee waivers for scientific advice:

For more information, see Fees payable to the European Medicines Agency.

How to apply

Eligibility requests for PRIME should be submitted via Eudralink to prime@ema.europa.eu, using:

When preparing their request, applicants should refer to:

Background

PRIME was developed in consultation with the Agency's scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network.

The final document ' PDF icon Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME) ' was adopted by the CHMP during its February 2016 meeting.

Toolbox guidance on developing robust PRIME quality data packages

Guidance is available for developers of medicines supported by EMA's PRIME scheme on the tools they can use to generate robust quality data packages for their marketing authorisation applications in the EU:

This guidance summarises scientific and regulatory approaches that medicine developers can use in their applications targeting unmet medical needs. This is meant to allow patients to benefit from the resulting therapies as early as possible.

This document aims to address common challenges with meeting quality and manufacturing development data requirements during development and at the time of marketing authorisation application.

It covers medicines containing chemical, biological or biotechnologically derived substances and advanced therapy medicinal products (ATMPs).

EMA published this guidance in April 2022, following a public consultation.

Background information

PRIME was developed in consultation with the Agency's scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network.

The final document ' PDF icon Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME) ' was adopted by the CHMP during its February 2016 meeting.

Topics

How useful was this page?

Add your rating
Average
6 ratings
7 ratings
1 rating
3 ratings
4 ratings