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  1. International Activities

International Engagements to Respond to Covid-19 Pandemic

CBER has substantially increased its international efforts in addressing the COVID-19 pandemic.  This includes regulatory and research collaborations regarding COVID-19 vaccine and convalescent plasma products.  By providing scientific and regulatory strategies to facilitate the development, authorization, and availability of COVID-19 vaccines and treatments, CBER contributes to the reduction and spread of COVID-19.

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During the pandemic, international regulatory agencies facing travel restrictions have shared inspection information. As with other FDA components, CBER has provided and received a wealth of inspectional information to and from its confidential partners. The CBER International Affairs Team has facilitated inspection information exchange through daily coordination and communication with international partners.

CBER participates in ongoing international pharmacovigilance efforts, including those organized by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). CBER’s collaborations with ICMRA facilitate information exchange during the ongoing COVID-19 pandemic among global health regulatory authorities. Also, CBER facilitates important exchanges of information and views on the following ICMRA Working Groups: COVID-19 Working Group, Pregnancy and Lactation in COVID-19, COVID-19 Pharmacovigilance Network, Observational Studies and Real World Evidence.

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CBER has a wide range of collaborations with the WHO to support preparedness and global response to the COVID-19 pandemic. CBER is actively engaged in the R&D Blueprint discussions on prioritizing COVID-19 vaccine research to address critical issues, including response to variants, in real time. CBER experts contribute to SARS-CoV-2 standards development activities and participate as members of WHO Working Groups on animal models and immune assays – activities that are integrally linked to global COVID-19 vaccine development efforts. As a national regulatory authority of reference, CBER has a significant role in WHO’s Emergency Use Listing (EUL) of two COVID-19 vaccines that are being used globally, and which are part of the U.S. vaccine donation program to increase access to COVID-19 vaccines in all regions of the world.

CBER has been proactive in sharing information with the WHO at the global level and through regional networks. Examples include CBER’s engagement with the African Vaccine Regulatory Forum (AVAREF) and collaboration with the African Union Smart Safety Surveillance (AU-3S) program which is focused on vaccine safety monitoring as immunization programs for COVID-19 are implemented in African countries. In addition to information sharing, these multilateral collaborations contribute to regulatory systems strengthening globally and increase preparedness to respond to the current and future public health emergencies.

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CBER continues to engage structured scientific and policy discussions under confidentiality commitments with foreign regulatory counterparts.  For example, CBER participates in regulatory “clusters” (working groups) with international partners such as the European Medicines Agency (EMA) and the Health Products and Food Branch of Health Canada.  Clusters are made up of regulatory experts who meet routinely to discuss regulatory and scientific issues of mutual interest.  CBER is a principal participant in the Clusters for Blood Products, Advanced Therapy Medicinal Products, and Vaccines, and additionally participates as appropriate in the Agency Oncology, Pediatric, Pharmacovigilance, Biosimilar and Pharmacogenomic Clusters. 

CBER participates in discussions in various cluster meetings to ensure a deeper understanding of agencies regulatory approaches and undertake mutual information sharing on COVID-19 products safety and efficacy, and inspection activities. CBER technical experts contribute to international COVID-19 vaccine safety efforts by participating in the FDA/EMA pharmacovigilance cluster.   

In addition, the CBER International Affairs Team collaborates with CBER scientific experts to identify strategic technical areas across CBER for which collaboration with foreign counterparts will add value to CBER’s mission.

The information sharing mutually complements the work CBER’s COVID-19 product authorization activities.  CBER utilizes the FDA Confidentiality Commitments tools for regulatory and research exchanges.  All agency confidentiality commitments are listed on the FDA website for reference.

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