FDA Issues Final Guidance on Emerging Drug Manufacturing Technologies
The US Food and Drug Administration (FDA) has issued final guidance, Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization, to provide recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to the FDA.
“While the implementation of emerging technology is critical to advancing product design, modernizing pharmaceutical manufacturing, and improving quality, [the] FDA also recognizes that the adoption of innovative approaches may represent challenges to industry and the Agency,” said the FDA in the guidance. “By the very nature of an approach being innovative, a limited knowledge and experiential base about the technology may exist. Pharmaceutical companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the new technologies and determine how they fit within existing regulatory framework,” the guidance says.
Acceptance of a request to participate in the program will depend on the applicant’s proposed plan for submission of an investigational new drug, original or supplemental abbreviated new drug application, biologics license application, or new drug application, or application associated drug master file based on two criteria. The planned submission should include one or more elements that will be subject to quality assessment for which the agency has limited review or inspection experience. In addition, the proposed technology in the planned submission should have the potential to improve product safety, identity, strength, quality, or purity (e.g., an innovative process design that can lead to a more robust and predictable production of quality pharmaceutical products).
In this program, pharmaceutical companies can, prior to the regulatory submission, submit questions and proposals about the use of specific emerging technology to a group within the FDA (emerging technology team – ETT), which includes relevant representation from all FDA pharmaceutical quality functions. The ETT works in partnership with relevant pharmaceutical quality offices and assumes a leadership or co-leadership role for the cross-functional quality assessment team (including review and on-site facility evaluation or inspection) for submissions involving emerging technology.