A Look Ahead at Manufacturing and Regulation

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches.
Jan 01, 2013

Dan Ward/Le Club Symphonie/Ian Nolan/Getty Images
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards and approaches for use in assessing the safety, effectiveness, quality and performance of products.

In October 2010, FDA issued a framework for advancing regulatory science for public health, which focused on the following: accelerating delivery of new medical treatments; improving paediatric and children's health; protecting against emerging infectious diseases and terrorism; enhancing safety and health through informatics; protecting the food supply; modernising safety testing; meeting challenges for regulating tobacco; and setting a collaborative implementation framework.

Following that framework, in August 2011, the agency released a strategic plan for advancing regulatory science at FDA, largely focused on science-based decision-making to improve public health. Part of this initiative identifies specific standards, methods and questions for drug reviewers to use in their review process. The overall effort builds upon the agency's Critical Path Initiative, launched in 2004, to drive innovation in scientific processes, which includes the 2011 report that prioritised eight areas, which included support for new approaches to improve product manufacturing and quality.

FDA has launched several Centres for Excellence in Regulatory Science and Innovation (CERSI) to carry out these priorities. The agency's initiative in regulatory science was also enhanced with the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012. Section 1124 of FDASIA calls for improving medical product decision-making through guidance documents and the adoption of tools, methods, and processes. The US Health and Human Services (HHS) Secretary must issue performance reports on these goals for fiscal years (FY) 2014 and 2016. Pharmaceutical Technology Europe (PTE) spoke to FDA about these issues in a special interview on the future of bio/pharmaceutical regulation.

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