Navigating the Future of Pharma Manufacturing with FDA’s Advanced Manufacturing Technologies Designation Program

Published on: June 27th, 2025

In December 2024, the U.S. Food and Drug Administration (FDA) unveiled the Guidance titled “Advanced Manufacturing Technologies Designation Program” (AMT Guidance), marking a transformative step for stakeholders in the pharmaceutical sector. We are excited to provide insights into how this program can refine your manufacturing strategies and enhance the competitiveness of your products in the market. 

Understanding the AMT guidance

The AMT Guidance aims to offer a clear pathway for the approval and designation of advanced manufacturing technologies used in the production of drugs, biological products, and other active ingredients. The goal is to encourage the adoption of innovative technologies that can improve the quality, safety, and efficiency of pharmaceutical manufacturing processes.

Eligibility criteria

A manufacturing method is eligible for AMT designation if it incorporates a new technology or a novel application of an existing technology to enhance drug manufacturing processes. This innovation should improve efficiency by reducing the development time for drugs and ensuring or increasing the supply of essential drugs, such as those that support or sustain life, or are crucial for healthcare, particularly those experiencing shortages.

Content of the request

An AMT designation request should include a brief description of the method of manufacturing and why it should be considered for AMT designation. Key points include ensuring drug quality through proposed control strategies, reducing drug development time, addressing critical drug supply needs, and overcoming perceived implementation challenges. It also requires data supporting the benefits of the AMT in maintaining or increasing drug supply and quality. In cases where there are no specific drug applications, using model drugs to illustrate the AMT’s potential impact is sufficient to request the designation.

Application process and timelines

The request will be evaluated by a cross-disciplinary team of ETT (Emerging Technology Team) or CATT (CBER’s Advanced Technologies Team) experts, including CDER and CBER members. FDA’s review period for AMT requests spans 180 calendar days from the date of receipt. Updates or proposed changes that could affect the context of use or eligibility of their designated AMTs must be communicated by AMT holders.

Comparison with other programs

AMT as well as CDER’s Emerging Technology Program and CBER’s Advanced Technologies Programs aim to enhance collaboration between the FDA and drug developers to address regulatory challenges and clarify issues surrounding new technologies that CDER or CBER are less familiar with. Despite sharing this common goal, they differ in terms of the maturity of the accepted technologies, as well as their timing, participants, and overall scope. 

Key benefits for stakeholders

Regulatory support: The designation program provides timely advice and engagement in additional communication with applicants for a drug manufactured using a designated AMT. 

FDA prioritized review: FDA will prioritize applicant interactions involving the use of a designated AMT in drug development or commercial manufacturing. Knowledge gained during the AMT designation process will be leveraged during FDA’s assessment of an application that uses a designated AMT.

Conclusion

The AMT Designation Program represents a pivotal moment for the pharmaceutical industry, paving the way for more efficient and innovative manufacturing practices. Embrace this opportunity to be at the forefront of pharmaceutical manufacturing excellence.