The US Food and Drug Administration (FDA) is looking for companies to participate in a program that will review the latest in cutting-edge pharmaceutical manufacturing technology.
For companies submitting an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufacturing technology, FDA wants to work with them on the quality section of their submissions (Chemistry Manufacturing and Controls and facility-related information).
The agency announced the program in a draft guidance issued Wednesday and intends to work with companies on a case-by-case basis. Based on its experience, FDA may develop future guidance and standards, as necessary, on emerging manufacturing technology.
“This guidance describes the concept that quality cannot be tested into products; in other words, it should be built-in or should be present by design,” FDA says, reiterating its approach to quality-by-design. “Quality is built into pharmaceutical products through a comprehensive understanding of the intended use of the product, the characteristics of the product, and the design of the product and manufacturing process using principles of engineering, material science, and quality assurance to ensure acceptable and reproducible product quality and performance throughout a product’s lifecycle.”
FDA said it intends to provide early engagement and additional meeting opportunities for the participants and FDA to discuss manufacturing design and development issues for innovative or novel product manufacturing technology, possibly related to the dosage form; manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or testing technology.
Manufacturers planning submissions should include one or more elements subject to quality assessment “for which the agency has limited review or inspection experience, where the technology has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable or cost-effective processes.”
FDA says it’s not putting a cap on the number of participating manufacturers and efforts will seek to ensure “that a wide variety of novel manufacturing technologies are included in this program.”
How to Participate
Interested companies planning to submit an IND or original or supplemental BLA or NDA and participate in this CDER program should submit a written request, three months prior to their application submission, for a Type C meeting and should specify the meeting request as a “Type C meeting – request to participate in the ETT program.”
Interested parties planning to submit an ANDA should submit a pre-ANDA meeting request and specify the meeting request as a “Pre-ANDA meeting – request to participate in the ETT program.”
The meeting request and related questions should be submitted electronically to CDER-ETT@fda.hhs.gov.
In addition to the items in the guidance, the request should also include: (1) A brief description of the proposed testing, process, and/or proposed technology; (2) A brief explanation why the proposed testing, process, and/or technology are substantially novel and unique and should be considered under this program; (3) A description of how the proposed testing and/or technology could modernize pharmaceutical manufacturing and thus improve product safety, identity, strength, quality, or purity; (4) A summary of the development plan and any perceived roadblocks to implementation (e.g., technical or regulatory); and (5) A timeline for a submission of IND, ANDA, BLA, NDA, original or supplemental.
FDA expects to notify companies of its decision regarding acceptance into the program in writing within 60 days of receipt of the request.
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry