The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3).
In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers.
In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies.
The use of the updated EU Module 1 Specification v3.0 and/or v3.0.1 is now mandatory for all eCTD format submissions in the EU. The use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. The use of XML delivery files has replaced the use of filenaming [...]
Use of the eAF v1.20 is now mandatory. Use of previous versions is accepted only for ongoing applications - the version of the form should not be changed in the middle of the procedure.
EMA eSubmission Gateway and Web Client unavailable on Tuesday evening 20 September 2016 for scheduled maintenance. The EMA eSubmission Gateway/Web Client will be unavailable on Tuesday 20 September 2016 between 18.00-19.00 UK time while scheduled upgrade work is carried out.
The Q3D Training Modules 8-9 (Module 8: Case Studies; Modules 9: FAQ document) can now be found on the ICH website. The Q3D Guideline aims to provide a global policy for limiting elemental impurities in drug products.
Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. The updated forms and related release notes are now available. Version 1.20 of the forms has been available for use since 14th June 2016 and will fully replace version eAF v. 01.19 after an extended transitional period on19 August [...]
Recordings from the webinar training on the use of the updated XML delivery files for submissions via the eSubmission Gateway held on 21st July and the interactive Questions and Answer sessions held on 25 and 26th July are now available.
The recording of the PSUR Repository v1.07 webinar training held on 25 July and recordings from the webinars on the Mandatory use are now available.