ICH Q11 Q&A (Selection and Justification of Starting Materials) now published on ICH webpage

The ICH Q11 Question and answer document reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). These Q&As are intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorization applications and/or drug master files. The focus of the Q&A document is on chemical entity drug substances.