This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology to FDA. The program is open to companies that intend the technology to be included as part of an investigational new drug application (IND) or original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance.
Issues in pharmaceutical manufacturing have the potential to significantly impact patient care in that failures in quality may result in product recalls and harm to patients. Additionally, failures in product or facility quality are a major factor leading to disruptions in manufacturing. Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. For example, contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies have the potential to decrease the risk of contamination from the processing line. Encouraging the development of emerging manufacturing technology may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle.
In this program, pharmaceutical companies can submit pre-submission questions and proposals about the use of specific emerging technology to a group within CDER (Emerging Technology Team – ETT). The ETT will work in partnership with relevant pharmaceutical quality offices and assume a leadership or co-leadership role for the cross-functional quality assessment team (including review and on-site Agency evaluation) for submissions involving emerging technology. The ETT will serve as the primary point of contact for companies that are interested in implementing emerging manufacturing technology in the manufacture of their drug products and for the relevant quality assessment team to:
(a) Answer sponsor/applicant questions about the information FDA expects to see in their submission;
(b) Identify and help facilitate regulatory review of a new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and Agency policy related to quality assessment;
(c) Serve as the lead or co-lead on the quality assessment team, in partnership with relevant CDER pharmaceutical quality offices, to review and make the final quality recommendation regarding the potential approval of submissions in the program; and
(d) Identify and capture resolution to policy issues that may inform FDA approaches and recommendations regarding future submissions that involve the same technology.