PhRMA, AdvaMed, AAM Support FDA’s Proposed GMP Alternatives for Combo Products
Industry groups PhRMA, AdvaMed and the Association for Accessible Medicines (AAM) have pledged their support for and sought further clarity on the US Food and Drug Administration’s (FDA) flexible ways by which combination products can comply with good manufacturing practice (GMP) requirements.PhRMA said it is “generally supportive” of the list developed by the agency as part of its obligations under the 21st Century Cures Act and appreciates FDA’s commitment to streamlining regulatory requirements for combination products.
In terms of the examples in the notice, PhRMA said it “believes that these examples codify current industry best practices and are helpful in confirming that industry is following the recommendations in FDA’s January 2017 ‘Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products.’”
But the group is seeking additional clarity “on certain elements of the mechanisms outlined in the notice in order to ensure regulatory flexibility and the streamlining of requirements. In addition, we strongly encourage FDA to adopt a more robust risk-based approach to determining exemptions of combination products from the device Quality System regulation (QSR).”
AdvaMed, meanwhile, commended FDA on the list but encouraged the agency to highlight combination product types and manufacturing processes for which GMPs vary from standard combination product CGMP requirements, and to describe in further detail alternative or streamlined approaches to meet CGMP requirements.
AAM similarly commended FDA on the list, noting that the examples of alternative mechanisms provided are “clear and useful.” But the group also sought more clarity on mechanisms for complying with the device QSR and on interacting with FDA on mechanisms for complying with CGMP.
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