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PEPFAR Activities within the Center for Biologics Evaluation and Research

PEPFAR Activities within the Center for Biologics Evaluation and Research

The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. PEPFAR is the cornerstone and largest component of the U.S. President’s Global Health Initiative. In recent years, the program has entered its second phase, moving from an emergency response modality to one of promoting sustainable country programs. The second phase also has seen a recognition by PEPFAR of the importance of regulatory systems strengthening, specifically in the area of medical devices used for diagnosis and treatment of HIV infection, to assure oversight of the quality, safety and efficacy of the diagnostics used in the program.

In support of PEPFAR’s regulatory systems strengthening efforts, CBER initiated efforts in partnership with PEPFAR, which have included training via an in-country regulatory workshop, and training of foreign regulators within FDA. Specific PEPFAR-funded efforts included a long-term training opportunity within CBER in the summer of 2015 for two regulators from the Tanzania Food and Drug Authority (TFDA) specializing in Medical Devices and Diagnostics, as well as a CBER-sponsored regional “Workshop on the Regulation of HIV Test Systems” held in Arusha, Tanzania in 2015 targeting sub-Saharan African regulators.

Training

CBER hosted two Medical Devices and Diagnostic Registration Officers from TFDA, for a three-month training term in Silver Spring, Maryland. TFDA staff became familiar with the laws, regulations and review principles that govern FDA regulatory review practices, while training in the evaluation and regulation of HIV test kits and blood donor screening assays. Hands-on and lecture training covered standardized reviewer training, and HIV-specific regulatory review training. Senior CBER staff member mentored the health professionals as they participated in Division and Test Development meetings, and coordinated training with active review teams.

Workshop

The “Workshop on the Regulation of HIV Test Systems” was held in Arusha, Tanzania on December 14-16, 2015. Coordinated by CBER, the workshop program faculty consisted of senior CBER scientists from the Office of Blood Research and Review, expert consultants, and staff from the World Health Organization (WHO). The program steering committee included stakeholders from FDA, WHO, TFDA, Centers for Disease Control and Prevention (CDC), East African Community (EAC), London School of Hygiene and Tropical Medicine (LSHTM), and other experts in the field of HIV Diagnostics familiar with the African regulatory landscape. The workshop audience consisted of foreign regulators from the medical device field, from twenty-two (22) countries as well as WHO AFRO, CDC, and the U.S. State Department. The Regional Medical Officer for Arusha Tanzania was a guest speaker.

The workshop supported an effort to increase regulatory capacity in the sub-Saharan Africa region, to support the availability, quality, and safety of medical products generally, and more specifically HIV test kits. The purpose of the workshop was to: strengthen the capacity of PEPFAR nations to lead in a response to the HIV epidemic; assist in the transition from an emergency response to promotion of sustainable country programs; and support the goal of nations to regulate HIV tests in their particular jurisdiction. The workshop provided an interactive and educational forum that addressed the principles of in vitro medical device (IVD) regulation, with specific emphasis on HIV test kits. Workshop topics included elements and challenges of a regulatory system, review of submission information, quality management systems, post-marketing activities, as well as hands-on team exercises on labeling of HIV diagnostic assays, and investigating/resolving complaints identified by end users of HIV diagnostic assays. Team deliberation, presentation of findings, and workshop discussion followed each hands-on activity.

WORKSHOP SLIDES