The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.

Common Repository will be unavailable between 07:00 and 09:00 on Wednesday, 30 August 2017 due to essential maintenance. If you have any questions, please contact the IT Service Desk.

At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality programmes based upon the scientific and regulatory principles outlined in ICH Guidelines.

Impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.

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.