The revised version of the ICH M4(R3) Guideline on the overall organisation of the CTD including the Granularity Document reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).
The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization (MSSO).
The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).
The Questions and Answers Document of the ICH S9 Guideline on Non Clinical Evaluation for Anticancer Pharmaceuticals reached Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3).
The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT).
The International Council for Harmonisation (ICH) met in Lisbon, Portugal, 11-16 June 2016...
Variation eAF: Due to an unexpected technical issue the publication of the updated version of the form is postponed to early next week. The hotfix version will be made available as soon as possible during the week commencing 27th June 2016.
CMDh SOP on the processing of PSUR single assessment for nationally authorised products (May 2016) [Track version]
A Question and Answer (Q&A) document on Membership and Observership can now be found on the ICH website. The Q&A document aims to address questions of potential applicants interested in ICH Membership and Observership.
The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step 3).