Manufacturers developing novel technologies may experience regulatory challenges as assessors determine how their products can be evaluated within existing regulatory frameworks.
The FDA’s Emerging Technology Programme (ETP) intends to address these concerns by helping industry gain regulatory approval for innovative technology drug applications.
Since 2014, the Agency’s Emerging Technology Team has worked with companies to identify and resolve roadblocks to technology implementation and regulatory approval of associated drug applications.
The programme has led to the approval of regulatory applications using innovative manufacturing methods for drugs and biologics, from advanced analytical tools to drug delivery systems.
To be accepted into the ETP, companies must propose manufacturing technologies that are novel or meet specific needs that benefit patients. Examples of accepted emerging technologies include 3D printing manufacturing, isolator and robotic arms for aseptic filling, and novel container and closure systems for injectable products.
“Response to the programme has been overwhelmingly positive, and FDA is working to streamline processes and enhance communication as it grows,” the Agency said.
FDA Emerging Technology Programme: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program
How to participate in the ETP: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/how-participate-etp
Examples of emerging technology: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/examples-accepted-emerging-technologies