8 July 2011

The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” The purpose of the addendum is to provide clarification of language in the original ICH S6 document regarding species selection, study design, immunogenicity, reproductive and developmental toxicity and carcinogenicity testing. The Addendum was integrated as Part II in the core S6 Guideline which was then renamed S6(R1). See the S6(R1) Guideline

The M3(R2) IWG, “Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals” finalized three sets of questions and answers at Step 4 which address limit dose, reversibility of toxicity, and metabolites. See the M3(R2) Q&As

The Quality Implementation Working Group (IWG) completed the ‘Points to Consider’ document on “Criticality of Quality Attributes and Process Parameters,” “Control Strategy,” and “Level of Documentation in Enhanced (QbD) Regulatory Submissions.” This document will serve to provide supplementary information to the previously completed Q&A’s and training materials.See the Quality PtC document