PRIME: priority medicines

PRIME is a scheme run 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.

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

By engaging with medicine developers early on, PRIME aims at improving scientific evidence-generation so the data generated is suitable for evaluating a marketing-authorisation application.

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

PRIME products benefit from enhanced support from EMA, tailored to the relevant stages of development.

EMA boosted its support measures and introduced a number of new features as of March 2023. 

This is based on a review of the first five years of the PRIME scheme.

Information is available in the table below and in the documents listed at the end of this section.  

All developers of products accepted onto the PRIME scheme benefit from the following: 

Small and medium-sized enterprises (SMEs) and applicants from the academic sector may be granted Early Entry PRIME status if they demonstrate proof of principle. EMA will offer them the benefits below:

Further information on key steps and support features following entry to PRIME is available in the documents below.

The PRIME scheme focuses on medicines under development that are not yet authorised in the EU. They target conditions with an unmet medical need - for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments.

To be accepted for PRIME, a medicine must demonstrate the potential to address an unmet medical need to a significant extent. This could mean, for example, introducing new methods of therapy or improving existing ones.

To justify such potential, applicants must provide any available data showing a meaningful improvement of clinical outcomes, such as:

• impacting the prevention, onset and duration of a given condition;
• improving the morbidity or mortality of a disease.

Any sponsor engaged in the exploratory clinical trial phase of development can submit a request to enter the PRIME scheme.

This is based on the availability of preliminary clinical evidence to demonstrate the promising activity of the medicine and its potential to address to a significant extent an unmet medical need, or proof of concept.

Earlier support for small businesses and researchers

Applicants from academia and SMEs, who generally have less experience of the regulatory landscape, may submit an eligibility request for Early Entry PRIME status if: 

• compelling non-clinical data in a relevant model provide early evidence of promising activity, or proof of principle;
• first-in-human studies indicate adequate exposure for the desired pharmacotherapeutic effects and tolerability. 

Did you know..? PRIME is not the right support vehicle for products that are already: in advanced development stages;  in the pre-submission phase of a marketing authorisation application; authorised in the EU, where a new indication is sought.

Medicine developers should use EMA's secure online IRIS platform to submit a PRIME eligibility request: 

The platform provides a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning a PRIME eligibility procedure. 

Before using IRIS to apply for PRIME, medicine developers need to complete the registration steps set out in the guidance document below.

For information and guidance on using IRIS, see the IRIS homepage.

Templates and application deadlines are available below. 

EMA offers pre-submission support to any applicant planning a PRIME application, including a virtual pre-submission meeting to discuss PRIME eligibility.

Applicants wishing to benefit from pre-submission support should contact prime@ema.europa.eu.

EMA uses research product identifiers (RPIs) to track medicines through pre-authorisation procedures.

The RPI replaces the previously used unique product identifiers (UPIs). EMA has converted previously assigned UPIs into RPIs.

Companies and individuals that approach EMA for the first time with a new medicinal product and do not have a previously assigned UPI / RPI, will need to request a new RPI via the IRIS platform.

Applicants receive the evaluation outcomes, via letter, following their adoption by CHMP.  

CHMP also adopts an overview of outcomes, which is then published in the CHMP meeting highlights. It contains limited information on the type of product, intended indication, level of data supporting the request, and type of applicant (SME, academia or other).

For products deemed eligible to PRIME, which is a positive outcome, CHMP makes public the name of the active substance / international non-proprietary name (INN). This is not the case for negative outcomes.

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.

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:

• Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need

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.

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 five 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. Applicants supported by PRIME, particularly SMEs, were able to answer questions from EMA's scientific committees in shorter timelines. 

It also calls for further improvements, including consideration of the best timepoint for applicants to enter the PRIME scheme, increasing the flexibility of scientific advice provision, and helping applicants better prepare for the marketing authorisation assessment phase.

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

For more information, see Key benefits for applicants.

To read the report, click on the thumbnail image in this section or find the document listed below.

The charts below provide key figures on PRIME eligibility requests.

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

Recommendations adopted by September 2023.

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

Type of applicants

Therapeutic areas

PRIME was developed in consultation with the EMA'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 draft reflection paper, overview and summary of comments, final document and list of stakeholders are available below.

The final document was adopted by the CHMP during its February 2016 meeting.