A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances has been detected and subsequently fixed. New version v.1.21.0.1 of the MAA veterinary form and the updated release notes are now available. Defects in section 1 and 3 of the Renewal eAF, affecting the MA Numbers fields and the overages field [...]
Symbicort pMDI (budesonide and formoterol fumarate dihydrate) End of procedure: 28/03/2017 Date of publication: 05/07/2017
Template for Active Substance Master File (ASMF) Type IB Variation Assessment Report (February 2025) [Track version]Template for Active Substance Master File (ASMF) Assessment Report (Applicant's Part) (February 2025) [Track version]Template for Active Substance Master File (ASMF) Assessment Report (Restricted Part) (February 2025) [Track version]
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements, new business rules and new fields to the user interface. Release notes detailing the changes are available here. Users should note that the delivery files created using the eSubmission Gateway XML delivery file [...]
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.
A presentation on the outcome of the first ‘proof of concept' User Acceptance Testing (UAT) on the Common European Single Submission Portal (CESSP) is now available here.
At the ICH meeting in Montreal, Canada, on 27 May to 1 June 2017, the ICH Assembly and ICH Management Committee made some revisions to the Articles of Association, Rules of Procedure and Standard Operating Procedures for Working Groups.
The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5).
The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017.
The ICH MedDRA Management Board met in Montreal, Canada on May 27-28, 2017 and announces its coordination with the WHO Collaborating Centre for International Drug Monitoring...