LAUSR.org creates dashboard-style pages of related content for over 1.5 million academic articles. Sign Up to like articles & get recommendations!

Reliance is key to effective access and oversight of medical products in case of public health emergencies

Photo from wikipedia

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… Click to show full 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.

Keywords: health emergencies; case public; public health; reliance

Journal Title: Expert Review of Clinical Pharmacology
Year Published: 2022

Link to full text (if available)


Share on Social Media:                               Sign Up to like & get
recommendations!

Related content

More Information              News              Social Media              Video              Recommended



                Click one of the above tabs to view related content.