User Acceptance Testing for eAF v1.22 outcome.In total 247 comments were received. We have fixed 62 defects (remaining defects will be assessed and prioritised in future releases). All submitted change requests will be analysed and prioritised.
From 1 December 2017, the use of Common Repository for Referral submissions replaces the use of CESP and CD/DVD for sending the Referral submissions to the National Competent Authorities (NCAs). All human referral submissions sent to the EMA will be considered delivered to all NCAs representatives and alternates. Submissions for all referrals should only be [...]
The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017.
The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017.
eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.3 and the related release notes are available. The updated eCTD validation criteria and related release notes are now available. The updated NeeS validation criteria and related release notes are now available. A draft release schedule for 2018 the electronic Application Form [...]
Updated versions of the Data Exchange Standard (DES) and XSD are now available on the eAF webpage for the next version of the electronic Application Forms (eAF). The updated CESSP Essentials presentation and a new CESSP question and answer document are now available on the CESSP webpage.
The ICH E18 Guideline on Genomic Sampling and Management of Genomic Data provides guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval.
Following its last meeting in Montreal in June 2017, the International Council for Harmonisation (ICH) has continued to progress its work
The ICH revised S5(R3) draft Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.
The ICH Management Committee identified the Expert & Implementation Working Groups to meet at the upcoming ICH meeting to take place in Geneva, Switzerland.