Itopride Date of publication:…
Itopride Date of publication: 18/10/2023
Lamotrigine Date of…
Lamotrigine Date of publication: 18/10/2023
Metoclopramide Date of…
Metoclopramide Date of publication: 18/10/2023
Azelastin Date of publication:…
Azelastin Date of publication: 18/10/2023
Amoxicillin/amoxicillin…
Amoxicillin/amoxicillin trihydrate Date of publication: 18/10/2023
Oxcarbazepine Date of…
Oxcarbazepine Date of publication: 18/10/2023
ICH Q9(R1) Quality Risk Management Training Materials now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.
eSubmission Gateway XML delivery file update for Article 18 submissions
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Human submissions (option to choose Article 18 as submission type).
Updated version of the VNeeS specification v3.1 now available
The guideline on eSubmissions for Veterinary products version 3.1 has now been published. It will enter into force on 1 November 2023 (see links under section Current Guidance).
Update on web based electronic Application Forms eAFs implementation
The electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of the web-based Human variations eAF implementation on Product Lifecycle Management (PLM) Portal.