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Reliance is key to effective access and oversight of medical products in case of public health emergencies.
Saint-Raymond, Agnes; Valentin, Marie; Nakashima, Nobumasa; Orphanos, Nick; Santos, Gustavo; Balkamos, Georgios; Azatyan, Samvel.
Afiliación
  • Saint-Raymond A; European Medicines Agency, International Affairs, Amsterdam, NL.
  • Valentin M; Regulation and Prequalification Department, World Health Organization (WHO), Geneva, Switzerland.
  • Nakashima N; International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Orphanos N; Office of policy and international collaboration, Health Canada, Ottawa, Canada.
  • Santos G; General Office of Medicines and Biological Products, ANVISA, Brasília, Brazil.
  • Balkamos G; Unit B4 - Medical products: quality, safety, innovation, European Commission, Brussels, Belgium.
  • Azatyan S; Regulation and Prequalification Department, World Health Organization (WHO), Geneva, Switzerland.
Expert Rev Clin Pharmacol ; 15(7): 805-810, 2022 Jul.
Article en En | MEDLINE | ID: mdl-35945703
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Salud Pública / COVID-19 Aspecto: Determinantes_sociais_saude Límite: Humans Idioma: En Revista: Expert Rev Clin Pharmacol Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Salud Pública / COVID-19 Aspecto: Determinantes_sociais_saude Límite: Humans Idioma: En Revista: Expert Rev Clin Pharmacol Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido