The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024.

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” has reached Step 2 of the ICH process on 5 February 2024.

This page lists the current members and alternates of the Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh).  For more information, see European expert declaration of interests and professional qualifications. For contact details, please refer to the affiliated organisations of individual committee members.

The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.

Diphtheria, Tetanus, Inactivated Poliomyelitis vaccine End of procedure: 18/08/2023 Date of publication: 31/01/2024

Report from the meeting held on 19-20 March 2024 Report from the meeting held on 20-22 February 2024 Report from the meeting held on 23-24 January 2024

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is available starting with 17 January 2024, 18:00 CET.

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is planned for release in the evening of 17th January 2024. This update will introduce a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document

From January 2024, EMA is launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications. Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission. The SEND package must be provided outside the [...]

Member: Petra Gubová Alternate: Kristína Ráczová State Institute for Drug Control Kvetná 11 SK-825 08 BRATISLAVA 26