Crisis Management during an Epidemic: General guidelines for efficient response coordination by national regulatory authorities, May 2020

Abstract

Considering the advance of the COVID-19 (novel coronavirus SARS-CoV-2) pandemic and the resulting declarations of health emergencies in the countries of the Region of the Americas, it is necessary to clarify the role and responsibility of each country’s National Regulatory Authority (NRA) regarding medicines and to establish appropriate channels for its participation in a coordinated strategy at the country level to provide an agile response in the pandemic. To ensure timely access to essential medicines and health technologies during the pandemic, countries will almost certainly need to develop, update, or even relax their regulatory frameworks, processes, and procedures. These actions may be necessary, for example, to use registered products for off-label uses, ensure the quality of donated products, deal with shortages of health products, etc. The actions that the NRA will implement must be effective and time-saving, which means that the country should create a coordinating group or committee with clear functions. The objective of this document is to provide guidance to NRAs on how to establish/review/implement regulatory committees for crisis management, how to coordinate with other health authorities, and how to promote improvements in communication with other government entities, civil society, and other relevant actors, in the framework of the regulatory response to the COVID-19 pandemic.