According to a recent report, the FDA is looking for companies to participate in a program that will review the latest in pharmaceutical manufacturing technology. The program applies to companies submitting an investigational new drug application (IND), original or supplement new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufacturing technology. FDA announced it intends to work with companies on a case-by-case basis on the quality section of their submissions.
Background
FDA’s CDER has a stated goal to support and enable the modernization of pharmaceutical manufacturing as a part of the FDA’s mission to protect and promote the public health. In 2002, FDA launched “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach,” to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. The initiative’s goals include encouraging the early adoption of new technological advances by the pharmaceutical industry and ensuring that regulatory review, compliance, and inspection policies are based on the latest science.
In 2004, FDA described this further in a guidance entitled PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. In the guidance, FDA describes the concept that quality cannot be tested into products. Rather, it should be built-in or present by design. Quality is built into pharmaceutical products through an understanding of the intended use of the product, its characteristics, and the design of the product and manufacturing process using principles of engineering, material science, and quality assurance to ensure acceptable and reproducible product quality and performance throughout a product’s lifecycle
Manufacturing process goals
Pharmaceutical manufacturing issues have the potential to significant impact the care of patients because failures in quality can result in product recalls and harm to patients. Failures in product or facilitate quality are also a major factor leading to disruptions in manufacturing. FDA hopes by promoting modern manufacturing technology, it could lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures, and greater assurance that the drug products manufactured will provide the expected clinical performance. The agency cites an example of an aseptic manufacturing facility that is highly automated and uses isolators and other separation technologies as a way to potentially decrease contamination from the process line.
Program structure
In the program, FDA states that pharmaceutical companies can submit pre-submission questions and proposals about the use of emerging technology to a group within CDER. The Emerging Technology Team (ETT) within CDER will work in partnership with other quality offices and assume a leadership role for the quality assessment team for submissions involving emerging technology.
The ETT will serve as the primary point of contact for companies that are interested in implementing emerging manufacturing technology in the manufacture of drug products. Examples of the ETT’s work include answering applicant questions about the information FDA expects to see in submissions; identifying and helping to facilitate the regulatory review of a new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and FDA policy related to quality assessment; an identify and capture resolution to policy issues that may inform FDA approaches and recommendations regarding future submissions that involve the same technology.
How to apply
Interested parties planning to submit an IND or original or supplement BLA or NDA as a part of this CDER program should submit a written request for a “Type C meeting” as described in other FDA guidance. The request should specify the meeting request as “Type C meeting – request to participate in the ETT program,” The request should be submitted at least three months prior to the planned application submission date. The meeting request and related questions should be submitted electronically to CDER-ETT@fda.hhs.gov. In addition, the request should also include:
- A brief description of the proposed testing, process, and/or proposed technology;
- A brief explanation why the proposed testing, process, and/or technology are substantially novel and unique and should be considered under the program;
- A description of how the proposed testing and/or technology could modernize pharmaceutical manufacturing and improve product safety, identity, strength, quality, or purity;
- A summary of the development plan and perceived roadblocks to implementation;
- A timeline for submission (IND, ANDA, BLA, NDA, original or supplemental).
FDA further notes the request document should generally not exceed five pages of narrative, including up to five figures or tables. The agency expects to limit acceptance into the program to technologies are that likely to modernize pharmaceutical manufacturing in order to improve product safety, identity, strength, quality, or purity, and with which FDA has limit prior experience and knowledge.
FDA expects to notify companies of its decision regarding acceptance into the program in writing within 60 days of receipt of the request. FDA may also contact the applicant to request additional information. If accepted, the participant can engage with the ETT and review teams in accordance with existing meeting procedures and guidances based on the availability of agency resources.