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)).
Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)
English (EN) (102.79 KB - XLSX)
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)
English (EN) (108.37 KB - XLSX)
Applications for new human medicines under evaluation: July 2025
English (EN) (103.79 KB - XLSX)
Applications for new human medicines under evaluation: June 2025
English (EN) (102.62 KB - XLSX)
Start of procedure: Type II variation - extension of indication (26 April - 22 May 2025)
English (EN) (109.28 KB - XLSX)
Start of procedure - extension of marketing authorisation (26 April - 22 May 2025)
English (EN) (104.25 KB - XLSX)
Applications for new human medicines under evaluation: May 2025
English (EN) (103.5 KB - XLSX)
Applications for new human medicines under evaluation: April 2025
English (EN) (104.21 KB - XLSX)
Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (28 February 2025 - 27 March 2025)
English (EN) (107.61 KB - XLSX)
Start of procedure: Extension of marketing authorisation (28 February 2025 - 27 March 2025)
English (EN) (104.42 KB - XLSX)
Applications for new human medicines under evaluation: March 2025
English (EN) (103.93 KB - XLSX)
Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (31 January - 27 February 2025)
English (EN) (106.91 KB - XLSX)
Start of procedure: Extension of marketing authorisation (31 January - 27 February 2025)
English (EN) (106.5 KB - XLSX)
Applications for new human medicines under evaluation: February 2025
English (EN) (103.65 KB - XLSX)
Applications for new human medicines under evaluation: January 2025
English (EN) (103.64 KB - XLSX)
Monthly lists - 2024
Applications for new human medicines under evaluation: December 2024
English (EN) (98.85 KB - XLSX)
Applications for new human medicines under evaluation: November 2024
English (EN) (99.08 KB - XLSX)
Applications for new human medicines under evaluation: October 2024
English (EN) (99.35 KB - XLSX)
Applications for new human medicines under evaluation: September 2024
English (EN) (99.58 KB - XLSX)
Applications for new human medicines under evaluation: August 2024
English (EN) (99.21 KB - XLSX)
Applications for new human medicines under evaluation: July 2024
English (EN) (774.32 KB - XLSX)
Applications for new human medicines under evaluation: June 2024
English (EN) (99.28 KB - XLSX)
Applications for new human medicines under evaluation: May 2024
English (EN) (816.88 KB - XLSX)
Applications for new human medicines under evaluation: April 2024
English (EN) (99.53 KB - XLSX)
Applications for new human medicines under evaluation: March 2024
English (EN) (99.39 KB - XLSX)
Applications for new human medicines under evaluation: February 2024
English (EN) (99.49 KB - XLSX)
Applications for new human medicines under evaluation: January 2024
English (EN) (563.08 KB - XLSX)
Monthly lists - 2023
Applications for new human medicines under evaluation by the CHMP: December 2023
English (EN) (99.08 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: November 2023
English (EN) (99.01 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: October 2023
English (EN) (99.06 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: September 2023
English (EN) (99.03 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: August 2023
English (EN) (99.85 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: July 2023
English (EN) (98.86 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: June 2023
English (EN) (98.76 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: May 2023
English (EN) (98.47 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: April 2023
English (EN) (98.65 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: March 2023
English (EN) (98.73 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: February 2023
English (EN) (99.09 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: January 2023
English (EN) (98.73 KB - XLSX)
Monthly lists - 2022
Applications for new human medicines under evaluation by the CHMP: December 2022
English (EN) (98.77 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: November 2022
English (EN) (109.4 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: October 2022
English (EN) (110.58 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: September 2022
English (EN) (111 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: August 2022
English (EN) (98.16 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: July 2022
English (EN) (110.1 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: June 2022
English (EN) (98.61 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: May 2022
English (EN) (98.68 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: April 2022
English (EN) (98.89 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: March 2022
English (EN) (99.24 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: February 2022
English (EN) (100.15 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: January 2022
English (EN) (99.26 KB - XLSX)
Monthly lists - 2021
Applications for new human medicines under evaluation by the CHMP: December 2021
English (EN) (99.69 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: November 2021
English (EN) (775.78 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: October 2021
English (EN) (99.12 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: September 2021
English (EN) (99.19 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: August 2021
English (EN) (98.77 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: July 2021
English (EN) (98.69 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: June 2021
English (EN) (98.72 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: May 2021
English (EN) (98.71 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: April 2021
English (EN) (98.27 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: March 2021
English (EN) (98.09 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: February 2021
English (EN) (97.28 KB - XLSX)
Applications for new human medicines under evaluation by the CHMP: January 2021
English (EN) (104.11 KB - PDF)