Outdated manufacturing technologies can lead to quality issues and recalls. But implementing the newest technologies isn’t easy either since there can be delays while reviewers familiarize themselves with the new technologies and determine whether or not they meet regulatory guidelines. Recognizing that the pharma industry is stuck between a rock and a hard place, the US FDA is looking to help smooth the introduction of new manufacturing methods with a new collaborative program. In draft guidance titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry,” the FDA explains that it is looking for companies to participate in a program where the FDA’s Emerging Technology Team (ETT) will work in partnership with pharmaceutical companies to assess and review submissions involving emerging technology (1).
“In order to encourage more advancements in pharmaceutical manufacturing, we recognized the need for a new approach, and established the ETT to work directly with industry to help identify and resolve scientific issues for new technologies,” explains a spokesperson for the FDA. “The initiative will encourage the adoption of innovative approaches to pharmaceutical manufacturing by leveraging existing resources within the Agency to facilitate the regulatory review of submissions to the Agency involving manufacturing technologies likely to improve product safety, identity, strength, quality, and purity.” Pharmaceutical companies will be able to engage in early discussions with the ETT regarding manufacturing design and development issues, and obtain FDA’s recommendations for regulatory submission content related to new manufacturing technology. In addition, when regulatory submissions involving novel manufacturing technology are received by FDA, the ETT will also work collaboratively with the pharmaceutical quality review offices to ensure timely assessment of the submission. “The continued involvement of ETT from the early technology development to application review will help ensure the consistency, continuity and predictability in the review and inspection of emerging technology,” adds the FDA. Since the guidance document provides recommendations, rather than establishing legally enforceable responsibilities, the FDA adds that the program is voluntary. Participants can apply to get involved by submitting a written request for a meeting with the FDA. Interested parties planning to submit an investigational new drug (IND) or an application for a new drug, biologic or generic that includes specific emerging technology, should send the request electronically to: CDER-ETT@fda.hhs.gov. “What makes this approach to emerging technology novel is that this dialogue with FDA and industry can occur during early technology development prior to the submission of a drug application to the FDA,” says Michael Kopcha, Director for the Center for Drug Evaluation and Research Office of Pharmaceutical Quality at the FDA. “Such early engagement allows the FDA to proactively identify and address potential roadblocks and helps eliminate potential delay in the adoption of promising new technologies.”
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References
- FDA, Draft Guidance, “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry,” (2015). http://1.usa.gov/1UrbhDP
