FDA issues final guidance, "Q11 Development and Manufacture of Drug Substances - Questions and Answers"

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities).”  The guidance, which was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH Q11 Guideline “Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).” The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.

FDA publishes ICH guidelines as FDA guidances.  FDA published a draft guidance on this topic in February 2017.  After consideration of the comments received and revisions to the guideline, the final guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in August 2017. 

The guidance reflects just one element in FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH.  One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies.  FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development.