PRIME: eligibility requests and outcomes

European Medicines Agency (EMA) publishes the monthly recommendations for the PRIME scheme and a list of medicines currently in it.
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The Committee for Medicinal Products for Human Use (CHMP) assesses PRIME eligibility requests and adopts recommendations on whether medicines are eligible for the scheme. 

EMA publishes the recommendations monthly on this page and in the CHMP Highlights and notifies applicants by letter.

The recommendations include positive and negative outcomes, with limited information on the product type, intended indication, level of supporting data and type of applicant (such as SMEs, academia or other organisations). 

For medicines granted PRIME support, CHMP publishes the name of the active substance / international non-proprietary name (INN). This information is not published for negative outcomes. 

EMA also updates a list of medicines currently in the PRIME scheme on a monthly basis. EMA removes medicines from the list when:

  • EMA receives a marketing authorisation application;
  • medicines are withdrawn from the scheme;
  • medicines no longer meet the eligibility criteria.

For more information on the PRIME scheme, see:

PRIME: priority medicines

List of medicines in PRIME scheme

Recommendations on eligibility to PRIME scheme

Eligibility of PRIME requests in figures

The charts show cumulative figures for PRIME eligibility requests up to the latest CHMP meeting.

Use the chart menu to view the data as a table or download the data in Excel and other available formats.

Eligibility of requests

Chart term explanation: 

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

Type of applicants

Therapeutic areas

Page update history

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 September 2026.

6 October 2026

  • New page published focused on  PRIME eligibility requests and outcomes and key eligibility request figures.

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