FDA Releases Draft Guidance on Emerging Manufacturing Technology

On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA program that allows pharmaceutical companies to submit pre-submission questions and proposals about the use of innovative technology to a group within the Center for Drug Evaluation and Research (CDER), entitled the Emerging Technologies Team (ETT).

According to the draft guidance, the ETT will work directly with pharmaceutical companies to evaluate proposals, serving as the primary point of contact within FDA for companies interested in implementing new manufacturing technology. The guidance states that the ETT will “facilitate regulatory review of new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and Agency policy related to quality assessment.” The ETT will assess if proposed technology will improve the quality of manufacture and make final recommendations to FDA about potential approval of technology.

In the past, FDA has proved to be a proponent of technological advances. The agency launched an initiative in 2002 entitled Pharmaceutical CGMPs for the 21^st Century: A Risk-Based Approach. One of the main goals of the 2002 initiative is encouraging new technology advances in the pharmaceutical industry. FDA stated the purpose of the initiative was to “encourage the implementation of a modern, risk-based pharmaceutical quality assessment system.”

In 2004, the agency released an additional guidance on manufacturing, entitled PAT‑A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance. The guidance discusses product quality, affirming that stable manufacturing processes ensure “acceptable and reproducible product quality.”

FDA admits there may be limitations to manufacturing innovations, stating that limited knowledge of new technology may prove challenging. In particular, FDA says there may be delays in the review process, as reviewers must familiarize themselves with new technology.

According to the agency, to participate in the new FDA program, applicants must submit a written request for a Type C meeting to CDER-ETT@fda.hhs.gov. Requests can include an explanation of the new testing, process, or proposed technology. Requests must be submitted three months prior to a planned application (Investigational New Drug, Abbreviated New Drug Application, Biologics License Application, or New Drug Application) date.