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FDA To Announce Actions Regarding Combination Products

18 January 2013
Final Rule on Combination Product cGMP
FDA To Announce Actions Regarding Combination Products

FDA today announced the release of a final rule on current good manufacturing practices (cGMP) for combination products. The rule, which will establish 21 CFR Part 4 – Regulation of Combination Products, is set for publication in the January 22 edition of the Federal Register, and will become effective 180 days after that.

The rule (similar in large part to the proposed rule published in 2009) addresses the practical application of cGMP requirements to combination products, which has been a confusing area of FDA practice for many years. There has been no clear regulatory framework that reflects the fact that combination products are made up of drug, device, and biological product constituents. In particular, the application of cGMP requirements to single-entity and co-packaged combination products has been less than straightforward.

Under the new rule, the sponsor of a single-entity or co-packaged drug/biologic-device combination product may meet its cGMP obligations by complying with all of the cGMP regulations applicable to each of the combination product’s constituent parts, or by complying with either the drug (or biologic) cGMP or the device quality systems regulation requirements, along with specified provisions of the other set of obligations.

FDA acknowledges that meeting any of the product-specific (e.g., drug, biologic, or device) cGMP requirements will essentially fulfill the substance of the sponsor’s compliance obligations with regard to the product as a whole, because the requirements for drugs, biologics and devices are for the most part substantially the same:

“[I]n most instances, for single-entity and copackaged combination products, a CGMP operating system that satisfies the CGMP regulations applicable to one constituent part will also satisfy most of the CGMP requirements applicable to the other constituent part. In particular, . . . compliance with either the CGMP regulations for drugs at parts 210 and 211 (21 CFR parts 210 and 211) (drug CGMPs) or the quality system (QS) regulation for devices at part 820 (21 CFR part 820) will satisfy many, though not all, of the CGMP requirements applicable to both drug and device constituent parts.”

Page 6 of attached final rule preamble.

Guidance on Modifications to Combination Products

The January 22 Federal Register also will announce the availability of a draft guidance on postapproval modifications to combination products. In the Federal Register notice, FDA says the draft guidance will “provide clarity in the postapproval change requirements and consistency in the type of postmarket submission to provide for a change to a combination product approved under one marketing application.”

HL Pharmaceutical & Biotechnology Team

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