FDA’s Office of Pharmaceutical Quality Publishes Annual Report

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The report details OPQ’s accomplishments over the past five years.

On February 10, 2020, the Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research (CDER) published is 2019 annual report. The report highlights OPQ’s accomplishments in drug assessment, inspection, surveillance, policy, and research over the past five years.

OPQ, which was established in 2015, has the task of ensuring drugs marketed in the United States meet quality standards. The office develops and implement science-based policies and prepares CDER quality guidance documents for branded, over-the-counter, and compounded drug products.

OPQ also conducts assessments of drugs developed under investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). These assessments review the design, manufacture, and testing of drugs as well as the quality of the facilities the drugs are manufactured in. OPQ also oversees the quality of marketed drugs throughout their lifecyles.

“The past five years have presented some significant challenges to OPQ, including an unprecedented number of regulatory submissions, new User Fee programs, urgent public inquiries, natural disasters, scientific advancements, and newly uncovered patient risks. To continue meeting the challenges of the future, OPQ has identified the priorities to work better together-to collaborate, to encourage innovation-to innovate, to educate about the importance of quality-to communicate, and to foster productive relationships with the public-to engage. These priorities are necessary to assure that quality medicines continue to be available to the American public over the next five years and many more to come,” the report states.


Some of the highlights from the report include OPQ’s work on the assessment of facility inspections prior to drug application approvals. According to the report, OPQ participated in 30% of 357 FDA application approval inspections in 2019. “When needed, this coordination ensures that a manufacturing facility is ready to deliver a drug with the same quality as proposed in the application,” the report states. The report points out that the number of generic-drug applications approved by FDA was 1014 in 2019, up from 726 approved in 2015. Also up is the number of biosimilar applications approved. In 2015, there were no biosimilar applications approved. In 2019, there were 10 approved. OPQ also expedited 194 quality assessments of applications in 2019 to avert drug shortages.

Source: FDA