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New CDER Guidelines For Drug Manufacturing Innovation and FDA

The pharmaceutical drug development industry has seen tremendous changes over the last 15 years. New research has turned into new drugs and therapies. New technology and devices have enabled scientists to see levels of detail never before seen. But there is one aspect of the drug development lifecycle that has been slow to change: drug manufacturing innovation. There are many reasons for this. Large molecule drug development is a costly operation, and tried and true processes are expensive to innovate; unlike replacing a bike tire, they often require change to the entire process. Small molecule drug development is more adaptable to innovation, but problems in scale up continue to plague the industry.

But the big hurdle for most companies involves manufacturing innovation and FDA regulation manufacturing processes, and ambiguity about which standards apply when seeking approval for an innovative process or unique technological approach. The adage, “If it ain’t broke, don’t fix it,” is not far off from the sentiment of drug manufacturers in scoping the cost in dollars and time delays for navigating a new approval pathway for pharmaceutical manufacturing innovation.

To provide impetus for change, the US Food and Drug Administration (FDA) has proposed a new program that promotes the adoption of manufacturing innovation. The Center for Drug Evaluation and Research (CDER) program guidelines “Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality,” are intended to “promote innovation in pharmaceutical development and manufacturing” and streamline the 33 standards involving compilation and assessment of marketing applications for products regulated by CDER.

The FDA CDER program would provide opportunities for FDA and pharmaceutical innovation stakeholders to propose pharmaceutical quality standards for consideration by the FDA that would ultimately impact drug manufacturing innovation. While quality is the focus of the guidelines, the true impact of this innovation is intended to reduce costs while improving efficiency and drug quality. The new risk-based guidelines will facilitate faster adoption of innovative technologies under existing FDA guidelines on manufacturing processes by outlining a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner.

In a February, 2019 statement from FDA Commissioner Scott Gottlieb, M.D., the new draft CDER guidelines are intended to provide transparency into the Agency’s thinking on standards as they apply to drug product applications, and to expedite review of those applications. The internationally accepted drug quality standards were developed in collaboration with regulators, industry and academia.

By providing a list of recognized standards on their website, the FDA hopes to help manufacturers to integrate innovative approaches and quickly understand regulatory acceptance criteria for a new method or approach. In doing so, the FDA, in turn, hopes to free up Agency time to refocus their efforts on other topics related to drug quality and cost-effective manufacturing. 

Link to Drug Manufacturing track of CPhI North America conference or https://cphinorthamerica.com/conference-overview.