FDA publishes Final Version of AMT (Advanced Manufacturing Technologies) Guideline

In early 2024, the FDA published a draft of the AMT Guideline to promote innovative manufacturing technologies. The FDA defines advanced manufacturing (AMT) as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of manufacturing processes. The FDA's goal with this program is to support the early implementation of advanced manufacturing technologies (AMTs) to ensure the supply of essential, life-saving or scarce medicines. The final version of the guideline describing the process for admission into the AMT program has now been published.

The FDA offers applicants whose technologies are recognized as AMTs closer collaboration and regular interactions aimed at identifying and resolving regulatory issues and problems at an early stage. To this end, companies are assigned a specific FDA contact person who acts as a liaison between the regulatory agency and the company and provides support during the authorization procedure. The FDA also provides early feedback so that companies can make adjustments before major investments are made.

The final version of the FDA guidance on the "Advanced Manufacturing Technologies Designation Program" contains several adjustments and extensions compared to the draft, which makes the document more comprehensible. The most important changes are:

• Clarification of the definition of Advanced Manufacturing Technologies (AMTs):
  The final version specifies that AMTs are innovative approaches in pharmaceutical manufacturing that are intended to improve the reliability and robustness of production processes and accelerate access to high-quality medicines.
• Expanded criteria for AMT approval:
  Specific criteria are listed that a technology must meet in order to be recognized as an AMT. For example, the FDA mentions continuous manufacturing, real-time process monitoring (Process Analytical Technology, PAT), 3D printing of drugs and automated inspection systems. The reduction of production risks can also lead to admission into the program, for example through the use of disposable technologies (single-use systems) that reduce the risk of cross-contamination. Contributions to sustainability, i.e. technologies that reduce the consumption of energy and resources in production, may also be considered, such as energy-saving cleanroom systems or water-saving cleaning technologies. 
• Detailed application requirements:
  The final version specifies the required content of an application for AMT status, such as a description of the technology, the scope of application, product quality data and potential regulatory challenges.
• Clarification of the submission process:
  A structured process for the submission and evaluation of AMT applications is described, including contact information and specific subject lines for communication with the FDA.
• Integration of a question-and-answer section:
  A new Frequently Asked Questions section provides additional clarity and details about the AMT program to simplify the process for potential applicants. What happens, for example, if an application is rejected? In this case, the FDA provides specific feedback on why the technology did not meet the requirements and what changes or additional information would be needed to resubmit the application.

The final FDA Guideline "Advanced Manufacturing Technologies Designation Program" is available on the FDA website.