Infanrix (Adsorbed Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed Pertussis antigens (Pertussis toxoid, Filamentous Haemagglutinin, Pertactin)) End of Procedure: 07/06/2018 Date of Publication: 03/08/2018

The ICH S9 Questions and Answers (Q&As) on the Nonclinical Evaluation for Anticancer Pharmaceuticals, reached Step 4 of the ICH Process in April 2018.

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), are intended to provide additional clarification

This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of [...]

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users to select correctly PASS 107 procedures types. Also, Purchase Order number attribute for PASS 107 procedure was introduced.

eSubmission CMB and CMB documents have been renamed eSubmission expert group and eSubmission expert group documents. The eSubmission CMB changed its name in June 2018 to better reflect its current status and tasks.

The document “Exceptions to the VNeeS format” has been updated. Please see the link in the section “Current Guidance” on the Veterinary eSubmission page.

The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.

The MedDRA Management Committee noted significant achievements in supporting the global expansion of MedDRA use

The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018.