Medicines for human use under evaluation

Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU).
HumanMedicines

For information on treatments and vaccines for COVID-19, including those under evaluation by the CHMP:

The CHMP meets once per month. Its evaluations of marketing authorisation applications submitted through the centralised procedure provide the basis for authorisation of medicines in Europe.

Monthly lists of medicines under evaluation by the CHMP are available dating back to 2012. They contain the international non-proprietary names (INN) and therapeutic areas of innovative medicines. The INN contains only the active moiety for generic medicines and biosimilar medicines, with no information on salt, ester or derivative. The lists are available in Excel format from February 2021 to support data sorting and filtering.

The CHMP's independent recommendations on medicine for human use are based on a comprehensive scientific evaluation of data. For information on how EMA evaluates medicines and the CHMP's role in the authorisation of medicines in the EU:

Monthly lists - 2025

As of March 2025, EMA publishes information - in Excel format - on the start of the procedures for extension applications and for type II variations that propose an extension of the authorised indication handled in IRIS.

This information features in addition to the monthly lists of medicines under evaluation also available below. 

It follows the transition of the post-authorisation regulatory procedures to IRIS. It is also in the context of the digitalisation of EMA's activities, and will help facilitate data analysis. 

As of January 2025, monthly reports of applications for new human medicines undergoing evaluation by the CHMP include:

  • a summary of the therapeutic indication applied for by the applicant;
  • date of re-start of the procedure, following submission of responses to the list of questions (at day 121 or at day 91 for applications under accelerated assessment, non-advanced therapy medicinal products (ATMPs)).

Monthly lists - 2024

Monthly lists - 2023

Monthly lists - 2022

Monthly lists - 2021

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