Improving the efficiency of the regulatory approvals of HIV in vitro diagnostics in low- and middle-income countries: Perspective of the IAS Industry Liaison Forum diagnostic partners.

In vitro diagnostics (IVDs) play a pivotal role in healthcare for the prevention, diagnosis, and treatment of infectious diseases, especially during epidemic and pandemic outbreaks. Improving access to IVDs holds promise for better healthcare outcomes, particularly in resource-limited settings. However, challenges persist, such as regulatory disparities and financial constraints, hindering broad access to IVDs. To address these challenges, the Industry Liaison Forum of the International AIDS Society convened regulatory agencies, industry stakeholders, and conducted research on IVD regulatory systems and practices in low- and middle-incomes countries. This paper synthesizes findings and makes recommendations from the Industry Liaison Forum diagnostic partners targeting key stakeholders to enhance regulatory capacity by embracing best practices and supporting initiatives improving diagnostic accessibility in resource-constrained settings. Converging regulations and reliance on internationally recognized approvals and standards can expedite access to diagnostics, including HIV diagnostics and monitoring tests without sacrificing quality or safety. This ongoing effort demands sustained engagement and collaboration. While challenging, improved regulatory frameworks promise significant benefits for global public health and end users. By fostering collaboration between industry, regulatory bodies, and other stakeholders, the Industry Liaison Forum aims to support a global effort to streamline regulatory processes, ultimately reducing barriers to accessing IVDs worldwide.