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The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step 5).
The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents for MedDRA version release 15.0.
In March 2012, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity and Juvenile Animal Studies.
The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).
In December 2011, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Combination Drug Toxicity Testing.
A comprehensive report of the last ICH meeting that was held in Seville, Spain on 5 - 10 November 2011 is now available on the ICH website under the SC Reports page.
At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process Validation/Continuous Process Verification.
At their meetings in Seville, in November 2011, the ICH E2B(R3) and M8 working groups finalised further documentation related to the development of ICH electronic standards.