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[交流] FDA-CDER’s Quality Initiative

CDER’s Quality Initiative

http://www.fda.gov/AboutFDA/Cent ... /CDER/ucm417014.htm

Quality is the underpinning of everything FDA does to help assure consumers have access to quality medicines, regardless of whether the medications are over-the-counter, prescription, innovator, or generic. Without quality, no one can be confident that a drug is safe and effective. To meet the needs of the global pharmaceutical market, we are working to enhance our robust drug quality program, similar to what the center has in place for drug safety and efficacy.

CDER’s Quality Initiative began more than a decade ago when the agency first introduced the 21st Century Initiative to modernize FDA’s regulation of the pharmaceutical quality of drugs. The initiative included issues related to product quality, with current good manufacturing practices as important tools for improving overall product quality.

The Food and Drug Administration Safety and Innovation Act of 2012 further enhanced CDER’s Quality Initiative by directing FDA to, among other things, improve its risk-based surveillance inspection schedule of manufacturing facilities. To implement this approach, FDA will use performance measures to assess a facility’s quality system to assure product quality. This practice will sharpen FDA’s focus on issues that are critical to quality and create a common language to gauge progress around quality. It will also allow FDA to identify and respond to quality issues at manufacturing facilities before those issues become major, systemic problems.

The Office of Pharmaceutical Quality (OPQ) further enhances CDER’s Quality Initiative by creating a drug quality program as robust as the programs the agency already has in place for drug safety and efficacy. OPQ will streamline FDA processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

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