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
The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6) Guideline, and the Q3C Support Documents 1, 2 and 3, which contain the summaries of the toxicity data from which the PDEs were derived for the original ICH Q3C Guideline, are [...]
The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines
Typhim Vi (Salmonella Typhimurium) End of procedure:13/07/2018 Date of publication: 02/10/2018