The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH Process in November 2016.

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period.

Information on how to submit electronic applications within MRP, DCP and National procedures via the CESP portal is found on the CESP (hma.eu) website.

The ICH MedDRA Management Board met in Osaka, Japan on November 5-6, 2016 and announces reductions in Subscription Rates for MSSO Subscribers....

The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016.

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.