Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs available now on the ICH website

Version 1.23.1.1 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.1 is a bug fix release providing usability improvements and technical defect fixes. This bug fix release does not affect the Data Exchange Standard (DES). This new version (v1.23.1.1) of the forms will fully replace the version 1.23.1.0 after transitional period, [...]

The minutes of the ICH Assembly meeting in Charlotte, NC, USA, in November 2018, available now on the ICH Website

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 08:00 (UK time)on Saturday, 15 December and 18:00 (UK time) on Sunday, 16 December 2018. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected [...]

Trileptal (Oxcarbazepine) DK/W/0028/pdWS/002 End of Procedure: 21/06/2018 Date of Publication: 28/11/2018 DK/W/0028/pdWS/003 End of procedure: 1/12/2021 Date of Publication: 22/11/2023        

The final version of the implementation package containing the updated eCTD v4.0 EU M1 Implementation Guide is now released for implementation purpose.

The International Council for Harmonisation (ICH) met in Charlotte, NC, USA on 10-15 November 2018.

The MedDRA Management Committee noted that 1 March 2019 will mark the 20 year anniversary of the first release of MedDRA.

The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier. [...]

Seretide Evohaler and related names (fluticasone propionate/salmeterol xinafoate End of procedure: 09/07/2018 Date of publication: 25/10/2018