Post-approval Changes to Combination Products - FDA Perspective

Recommendation

2/3 May 2024

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Now that the ICH Q 12 guideline on pharmaceutical product life cycle management has also been implemented in the US, guidance on this topic will follow. In a new guideline "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA", combination products are also addressed.

Using a standardised approach, ICH Q12 defines the categorisation of post-approval changes to Chemistry, Manufacturing, and Controls (CMC), Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs) and Product Lifecycle Management (PLCM) concepts. Post-approval changes can thus be made more easily, as specifications for them are already named in advance. This then runs via a post-approval change management protocol. In the US, this protocol is called "Comparability Protocol" (CP).  

The FDA guidance also deals with changes to a "combination product" (medicinal product with a medical device component or biologicals with a medical device component) in the sense of the ICH Q12 guideline. In a question and answer section, the question is also addressed whether the FDA has recommendations for changes to a combination product in a CP.

However, the answer is very generic. In general, a CP can be submitted for the changes if CDER or CBER is the lead centre. The impact on the medical device of the change should be considered. For further questions, the guideline recommends contacting the respective FDA´s  review division.   

Please see the FDA website for the Guidcance "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA".