USA – Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH).

The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates and the unfinished and final drug substance; synthetic manufacturing process changes; changes in the source of drug substance; and changes to container closure system of the drug substance.

In comments filed late last month, Sanofi noted that the guidance refers to various ICH guidance documents (e.g., referring to Q7, Q8(R2), Q9, Q10, Q11, and M7), but, “It does not seem to incorporate many of the approaches and concepts for simplification of post-approval changes that have been included in ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management.”

It is also unclear whether FDA plans to update this guidance once Q12 is finalized. Therefore, Sanofir requests that FDA clarify its views on this in the final version of the guidance, “to help ensure that FDA’s requirements and expectations are harmonized with those set forward in ICH Q12, once that guideline becomes effective.”…