FDA Issues Final Guidance On CGMP Requirements For Combination Products

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) has released final guidance on current good manufacturing practice (CGMP) requirements for combination products.

The 59-page final guidance defines a combination product, under 21 CFR part 3, as a product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another). It also contains an overview of the agency's final rule for CGMP requirements for combination products, which was released in 2013 and codified in 21 CFR Part 4, and also included in the draft version released in January 2015. The final guidance discusses the purpose and content of specific CGMP requirements addressed in the final rule.

In separate sections, FDA describes the role of the lead center and other agency components with respect to combination product CGMP issues, and addresses certain general considerations for CGMP compliance for combination products. The final guidance also provides hypothetical scenarios that illustrate for manufacturers and sponsors how to comply with certain CGMP requirements for specific types of combination products — in particular, a prefilled syringe, a drug-coated mesh, and a drug-eluting stent (DES).

According to RAPS, FDA said it reviewed comments for the draft guidance and, “where possible, has incorporated into the final guidance additional detailed discussion of how the requirements apply and acceptable CGMP compliance approaches. FDA encourages combination product manufacturers to contact the lead Center for their combination product and/or the Office of Combination Products if they have questions on CGMP compliance or approaches they are considering for meeting CGMP requirements.”

FDA said it also used for this final guidance other existing guidance and additional resources that address CGMP requirements for drugs, devices, biological products, and HCT/Ps (human cells, tissues, and cellular and tissue-based products).

Medical device and pharmaceutical companies, as well as industry groups, have called on FDA to provide more clarity with regard to its regulatory oversight of combination products, which undergo a complex review process involving different FDA centers, each with their own requirements.

In response, the federal agency last year introduced a series of measures designed to further facilitate reviews and bring combination products to market faster.

In April, it created the Combination Products Policy Council, which has decisional authority on issues relating to combination products. Four months later, in August, it started the pilot phase of a new intercenter consult request (ICCR) process. The pilot is expected to finish in the second quarter of 2017. Also in August last year, FDA debuted a pre-request for designation process for sponsors contemplating a specific configuration of their combination product at its early stage of development.

Last month, FDA issued the final rule describing the postmarketing safety reporting requirements for combination products.