In the pharmaceutical industry, advanced manufacturing signifies an innovative approach or technology aimed at enhancing the reliability and robustness of the manufacturing process and supply chain.
This advancement facilitates timely access to quality medicines by integrating novel technological approaches, leveraging established techniques innovatively, or implementing production methods in uncharted territories where conventional best practices are lacking.
This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs manufactured using an AMT that has been designated as such under the program (hereinafter designated AMT). The guidance outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation and includes a questions and answers section to cover additional details about key concepts important for program utilization. Specifically, the guidance describes:
The process for submitting an AMT designation request, including a description of eligibility criteria and the data and other information to be included.
• When and how FDA will assess AMT designation requests.
• The process by which FDA will engage with requestors, holders of designated AMTs, and applicants for drugs manufactured using, referencing, or relying upon a designated AMT.
• Benefits related to drug development and application assessment.4