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.
The ICH E11(R1) draft Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process and is currently under public consultation.
ICH E6(R1) on Good Clinical Practice (GCP) has been amended to encourage implementation of improved and more efficient approaches to clinical trials design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
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.