Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”

Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (October 2022)

On October 13, 2022, the FDA (CDER and CBER) issued the Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (NDA/ANDA/BLA Chemistry/Manufacturing/Control Information Postapproval Change Comparability Protocols) guidance. The draft guidance was issued in 2003 and 2016, respectively. The official draft guidance represents the FDA's latest thinking on this topic. The release of the official draft will help pharmaceutical companies to more accurately understand the FDA's thinking on CMC-related changes, and guide holders to submit drug changes to the FDA through the use of comparability protocols (CP) in the first application and approved products.

CP is a comprehensive, forward-looking written plan that holders use to evaluate the impact of proposed CMC changes that may be related to product safety or effectiveness on the characteristics, specifications, quality, purity and potency of drugs (including biologics). Submitting a CP in the original application or a major change (PAS) for an approved product allows the FDA to review one or more possible post-approval CMC changes, related supporting information and analysis, including risk assessments and change implementation plans. This may allow the drug to enter sales or help speed up the construction of the drug supply chain.

"CMC Post-Approval Change Comparability Program" Guidance Official Draft