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 are 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:
| 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 |
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:
| Benefit | Stage | More details |
|---|---|---|
| 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. |
| Total fee exemption for scientific advice to applicants from the European Economic Area (EEA) | At any stage | Further promotes engagement via scientific advice |
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:
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:
 Did you know..? PRIME is not the right support vehicle for products that are already:
|
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 can submit these requests via IRIS.
The following PRIME procedures are also available in IRIS:
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.
The information is also contained in the annexes of the monthly CHMP highlights.
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.
A joint question-and-answer (Q&A) guidance document is available from EMA and the United States Food and Drug Administration (FDA) for medicine developers on how to address quality development and good manufacturing practice (GMP) challenges when developing medicines under early access schemes, such as EMA's PRIME or FDA's Breakthrough Therapies.
It covers the following:
The Q&As are a result of follow-up discussions to a 2018 stakeholder workshop on these topics.
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.
Read EMA's 5-year report on the PRIME scheme
The report covers data collected between March 2016 and June 2021.
For more information, see Key benefits for applicants.
The charts below provide key figures on PRIME eligibility requests.
They show the cumulative recommendations up to the latest CHMP meeting.
Recommendations adopted by October 2024.
* Out of scope applications are not included in the breakdown by type of applicants or therapeutic areas
** Application for transition from early entry to full PRIME eligibility
Eligibility of PRIME requests
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.
