FDA Finalises Guidance on Emerging Technology Applications

The Guidance "Emerging Technology Applications for Pharmaceutical Innovation and Modernization" was already published as a draft in December 2015 - entitled "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base".

The document's intention has not changed. The FDA still calls on pharmaceutical companies to participate in a programme for the submission of applications that contain new technologies. This applies to new submissions as well as to supplements, to biological and classical approval applications (IND, ANDA, NDA BLA and DMF). The FDA defines new technologies as follows:
"[…, emerging technology should be novel in the context of the pharmaceutical and related industries and it should have the potential to modernize the pharmaceutical manufacturing body of knowledge related to product quality. Emerging technology will be new to FDA in the context of pharmaceutical quality, with limited prior experience and knowledge.]."

In detail, this means: New production technologies, new container closure systems, new process design/scale-up or lifecycle approaches as well as new control strategies or testing technologies.

The FDA expects this to result in more innovations in the pharmaceutical industry and, subsequently, in a higher quality level of the products. That way, the approval procedure should be simplified for the participating companies.

Interested companies may send a form for a so-called "Type C meeting" to the FDA to request a meeting. Further details can be found in the "Formal Meetings between FDA and Sponsors or Applicants" guidance.