In November 2016, the ICH Assembly and Management Committee met in Osaka, Japan, for their biannual meeting.

The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF) (May 2024) [Track version] Training presentations on Active Substance Master File (ASMF) work sharing procedure:

In November 2016, the Board approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors, and product quality issues.

The Common Technical Document (CTD) is organised into five modules, including as an Annex the Granularity document that provides guidance on document location and paginations.

In November 2016, the ICH MedDRA Management Committee (MC) approved the MedDRA MC Rules of Procedures developed to provide guidance and interpretation in respect of the provisions of the Articles of Association relating to the MedDRA MC.

In November 2016, the ICH Assembly approved the 2017 ICH Work Plan and Multi-annual Strategic Plan, as well as the 2017 MedDRA Work Plan. These documents provide objectives and timelines in respect of the goal of the ICH Association.

The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct.

This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.

The ICH Q3C(R6) Guideline reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).