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).

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

• COVID-19 medicines

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:

• Authorisation of medicines
• Committee for Medicinal Products for Human Use (CHMP)

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)).

Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)

Reference Number: EMA/244908/2025

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)

Reference Number: EMA/244915/2025

Applications for new human medicines under evaluation: July 2025

Reference Number: EMA/134672/2025

Applications for new human medicines under evaluation: June 2025

Reference Number: EMA/187336/2025

Start of procedure: Type II variation - extension of indication (26 April - 22 May 2025)

Reference Number: EMA/179155/2025

Start of procedure - extension of marketing authorisation (26 April - 22 May 2025)

Reference Number: EMA/179147/2025

Applications for new human medicines under evaluation: May 2025

Reference Number: EMA/153582/2025

Applications for new human medicines under evaluation: April 2025

Reference Number: EMA/124951/2025

Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (28 February 2025 - 27 March 2025)

Reference Number: EMA/112150/2025

Start of procedure: Extension of marketing authorisation (28 February 2025 - 27 March 2025)

Reference Number: EMA/112158/2025

Applications for new human medicines under evaluation: March 2025

Reference Number: EMA/83261/2025

Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (31 January - 27 February 2025)

Reference Number: EMA/78066/2025

Start of procedure: Extension of marketing authorisation (31 January - 27 February 2025)

Reference Number: EMA/78061/2025

Applications for new human medicines under evaluation: February 2025

Reference Number: EMA/51244/2025

Applications for new human medicines under evaluation: January 2025

Reference Number: EMA/5196/2025

Monthly lists - 2024

Applications for new human medicines under evaluation: December 2024

AdoptedReference Number: EMA/561462/2024

Applications for new human medicines under evaluation: November 2024

Reference Number: EMA/512631/2024

Applications for new human medicines under evaluation: October 2024

Reference Number: EMA/459172/2024

Applications for new human medicines under evaluation: September 2024

Reference Number: EMA/414559/2024

Applications for new human medicines under evaluation: August 2024

Reference Number: EMA/368078/2024

Applications for new human medicines under evaluation: July 2024

Reference Number: EMA/320819/2024

Applications for new human medicines under evaluation: June 2024

Reference Number: EMA/273906/2024

Applications for new human medicines under evaluation: May 2024

Reference Number: EMA/2018069/2024

Applications for new human medicines under evaluation: April 2024

Reference Number: EMA/140936/2024

Applications for new human medicines under evaluation: March 2024

Reference Number: EMA/97964/2024

Applications for new human medicines under evaluation: February 2024

Reference Number: EMA/58689/2024

Applications for new human medicines under evaluation: January 2024

Reference Number: EMA/9538/2024 Corr.

Monthly lists - 2023

Applications for new human medicines under evaluation by the CHMP: December 2023

Reference Number: EMA/553110/2023

Applications for new human medicines under evaluation by the CHMP: November 2023

Reference Number: EMA/989140/2023

Applications for new human medicines under evaluation by the CHMP: October 2023

Reference Number: EMA/444135/2023

Applications for new human medicines under evaluation by the CHMP: September 2023

Reference Number: EMA/401841/2023

Applications for new human medicines under evaluation by the CHMP: August 2023

Reference Number: EMA/350192/2023

Applications for new human medicines under evaluation by the CHMP: July 2023

Reference Number: EMA/309551/2023

Applications for new human medicines under evaluation by the CHMP: June 2023

Reference Number: EMA/207108/2023

Applications for new human medicines under evaluation by the CHMP: May 2023

Reference Number: EMA/207107/2023

Applications for new human medicines under evaluation by the CHMP: April 2023

Reference Number: EMA/164278/2023

Applications for new human medicines under evaluation by the CHMP: March 2023

Reference Number: EMA/104578/2023

Applications for new human medicines under evaluation by the CHMP: February 2023

Reference Number: EMA/58424/2023 corr

Applications for new human medicines under evaluation by the CHMP: January 2023

Reference Number: EMA/13171/2023

Monthly lists - 2022

Applications for new human medicines under evaluation by the CHMP: December 2022

Reference Number: EMA/932370/2022

Applications for new human medicines under evaluation by the CHMP: November 2022

Reference Number: EMA/855051/2022

Applications for new human medicines under evaluation by the CHMP: October 2022

Reference Number: EMA/822461/2022

Applications for new human medicines under evaluation by the CHMP: September 2022

Reference Number: EMA/784941/2022

Applications for new human medicines under evaluation by the CHMP: August 2022

Reference Number: EMA/685123/2022

Applications for new human medicines under evaluation by the CHMP: July 2022

Reference Number: EMA/623957/2022

Applications for new human medicines under evaluation by the CHMP: June 2022

Reference Number: EMA/564600/2022

Applications for new human medicines under evaluation by the CHMP: May 2022

Applications for new human medicines under evaluation by the CHMP: April 2022

Reference Number: EMA/203848/2022

Applications for new human medicines under evaluation by the CHMP: March 2022

Reference Number: EMA/144373/2022 Corr.

Applications for new human medicines under evaluation by the CHMP: February 2022

Reference Number: EMA/71693/2022 Corr.

Applications for new human medicines under evaluation by the CHMP: January 2022

Reference Number: EMA/4718/2022

Monthly lists - 2021

Applications for new human medicines under evaluation by the CHMP: December 2021

Reference Number: EMA/726376/2021

Applications for new human medicines under evaluation by the CHMP: November 2021

Reference Number: EMA/625035/2021

Applications for new human medicines under evaluation by the CHMP: October 2021

Reference Number: EMA/569084/2021

Applications for new human medicines under evaluation by the CHMP: September 2021

Reference Number: EMA/491283/2021

Applications for new human medicines under evaluation by the CHMP: August 2021

Reference Number: EMA/444323/2021

Applications for new human medicines under evaluation by the CHMP: July 2021

Reference Number: EMA/373584/2021

Applications for new human medicines under evaluation by the CHMP: June 2021

Reference Number: EMA/316655/2021

Applications for new human medicines under evaluation by the CHMP: May 2021

Reference Number: EMA/247078/2021

Applications for new human medicines under evaluation by the CHMP: April 2021

Reference Number: EMA/201519/2021

Applications for new human medicines under evaluation by the CHMP: March 2021

Reference Number: EMA/151574/2021

Applications for new human medicines under evaluation by the CHMP: February 2021

Reference Number: EMA/75461/2021

Applications for new human medicines under evaluation by the CHMP: January 2021

Reference Number: EMA/1722/2021