PRIME enables EMA to offer early and proactive support to medicine developers. This helps optimise the generation of robust data on a medicine's benefits and risks, and enable accelerated assessment of medicines applications.
Ultimately, PRIME will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
This scheme builds on an 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.
PRIME also aims to improve scientific evidence-generation, so the data generated are suitable for evaluating a marketing-authorisation application. The scheme does so by engaging with medicine developers early on.
Early dialogue and scientific advice also ensure that patients only participate in necessary trials designed to generate the necessary data. This makes the best use of limited resources.
For more information on EMA's role in medicine research and development, see:
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:
PRIME is not the right support vehicle for products that are already:
PRIME products benefit from enhanced support from EMA, tailored to the relevant stages of development.
| Benefit | Stage | More details |
|---|---|---|
| Early appointment of CHMP or CAT rapporteur | One month after PRIME eligibility is granted | Discussion on technical and scientific preparatory aspects of the marketing authorisation application |
| Kick-off meeting with rapporteur and multidisciplinary group of experts from EMA / European medicines regulatory network | Three-four months after PRIME eligibility is granted | Guidance on overall development plan, future scientific advice and regulatory strategy |
| Appointment of PRIME Scientific Coordinator | Immediately after PRIME eligibility is granted | Dedicated EMA contact point to coordinate all support provided through PRIME |
| Iterative scientific advice on overall development plans and key issues | At any stage, and at major development milestones | Opportunity to involve other stakeholders such as health technology assessment (HTA) bodies, patients and the US Food and Drug Administration (FDA) |
| Expedited follow-up scientific advice (under certain criteria) with shortened timelines | At any stage | Increased flexibility in providing scientific advice and a shortened timeline for related procedures |
| Submission readiness meeting | Approximately one year ahead of marketing authorisation application | Discussion on development status and dossier maturity, application type (e.g. conditional marketing authorisation application), post-marketing evidence-generation and potential regulatory challenges |
| Confirmation of potential accelerated assessment | At time of marketing authorisation application | Increased certainty of assessment timelines |
SMEs and applicants from the academic/non-for-profit sector may be granted Early Entry PRIME status if they demonstrate proof of principle. EMA will offer them the benefits below:
| Benefit | Stage | More details |
|---|---|---|
| Appointment of PRIME Scientific Coordinator | Immediately after PRIME eligibility is granted | Dedicated EMA contact point to coordinate all support provided through PRIME |
| EMA product team | Immediately after PRIME eligibility is granted | Advice on plans to generate the proof of concept data required to transition to full PRIME status, which triggers the CHMP / CAT rapporteur appointment |
| Introductory meeting to raise awareness of regulatory requirements | Three-four months after PRIME eligibility is granted | Scientific and regulatory advice on the overall development plan and at major milestones, with an opportunity to involve stakeholders such as HTA bodies, patients and the US FDA. |
| Iterative scientific advice (including expedited scientific advice) on overall development plans and key issues | At any stage | Scientific and regulatory advice on the overall development plan and at major milestones. |
| Expedited follow-up scientific advice (under certain criteria) with shortened timelines | At any stage | Increased flexibility in providing scientific advice and a shortened timeline for related procedures |
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.
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:
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.
EMA offers pre-submission support to any applicant planning a PRIME application, including a virtual pre-submission meeting to discuss PRIME eligibility. Applicants can submit these requests via IRIS.
The following PRIME procedures are also available in IRIS:
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 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 approaching EMA for the first time with a new medicine may not yet have a UPI/RPI. In such cases, they will need to request a new RPI via the IRIS platform.
Guidance on the key steps and support features following entry to PRIME is available in the documents below.
Guidance is available on the tools developers 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.
A joint question-and-answer (Q&A) guidance document is available from EMA and the United States Food and Drug Administration (FDA). It informs on how to address quality development and good manufacturing practice (GMP) challenges when developing medicines under early access schemes. Early access schemes include EMA's PRIME FDA's Breakthrough Therapies.
It covers the following:
The Q&A is a result of follow-up discussions to a 2018 stakeholder workshop on these topics.
PRIME was developed in consultation with:
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.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
