Reliance is key to effective access and oversight of medical products in case of public health emergencies. Issue 7 (3rd July 2022)

• Record Type: Journal Article
• Authors: Saint-Raymond, Agnes; Valentin, Marie; Nakashima, Nobumasa; Orphanos, Nick; Santos, Gustavo; Balkamos, Georgios; Azatyan, Samvel
• Is Part Of: Expert review of clinical pharmacology. Volume 15:Issue 7(2022)
• Page Start: 805
• Page End: 810
• Publication Date: 2022-07-03
• Subjects: COVID-19 -- emergency use authorization -- emergency use listing -- international collaboration -- international pharmaceutical regulators programme -- public health emergencies -- regulatory authorities -- reliance -- vaccines -- WHO; Clinical pharmacology -- Periodicals; 615.105
• DOI: 10.1080/17512433.2022.2088503
• Languages: English
• ISSNs: 1751-2433

Abstract

ABSTRACT: Introduction: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, rapid and coordinated actions, and reliance mechanisms were key elements of the regulators' response to COVID-19 for all regulatory functions. Areas covered: This article presents how collaboration and reliance among regulators were crucial tools for the regulatory responses to COVID-19, describes the reliance approaches for authorization of COVID-19 vaccines and other commodities, and the importance of reliance for other regulatory functions to avoid duplication and save resources where possible. This article also presents the results of a follow-up survey of reliance approaches in case of public health emergencies conducted between the International Pharmaceutical Regulators Programme (IPRP) members and discusses the forward-looking potential of reliance, analyzing the journey from theoretical concepts to real-life implementation. Expert opinion: Regulatory reliance is an essential tool for regulators to act quickly and collectively in times of public health emergencies. Reliance approaches facilitate regulatory approvals and allow a more efficient use of resources, ultimately serving patients by facilitating earlier access to quality assured, safe and effective medicines.