Functional regulatory systems are particularly crucial to achieving equitable access to quality-assured and safe medical products during pandemics and other public health emergencies.  Under these circumstances unregistered, investigational or candidate medical products might be used with a minimum set of quality, safety and efficacy data.  During the 2009 pandemic and more recent pandemics, Ebola and COVID-19, a lack of well-functioning national systems for regulatory approval was identified as one of the potential barriers for countries’ timely receipt and deployment of medical products.

Therefore, engaging National Regulatory Authorities (NRAs) in the inter-pandemic period, supporting their regulatory preparedness plans, and strengthening necessary regulatory capacities is critical and will help reduce or eliminate country-specific regulatory delays during a pandemic. Responding to a public health emergency – for example, an emerging infectious disease – requires decision-making in a context that is different from “business as usual.”  Being prepared with the necessary plans and tools, and being rehearsed, is just as essential for regulators as for other stakeholders in an emergency situation.  WHO has considerable experience in helping regulators improve and test their systems’ preparedness so that they are sufficiently robust and responsive in a public health emergency.  However, many low- and middle-income countries particularly remain inadequately prepared.

To respond to the 2009 pandemic, the Pandemic Influenza Preparedness (PIP) Advisory Group in 2012, recommended investing PIP partnership contributions on regulatory system capacity building in priority countries.  The outcome sought was to enable countries with limited regulatory system capacity in regulating influenza products, including vaccines, antivirals and diagnostics for pandemic influenza to accelerate national approval of these commodities in case of Pandemic Influenza.  Fore recently, WHO’s five-year plan (2019–2023) to help build effective and efficient regulatory systems, identified increasing regulatory preparedness for public health emergencies as one the four strategic priorities.  In this plan, WHO expects that at least 10 countries will have improved their regulatory infrastructure to address the specific challenges of public health emergencies, adopting features such as regulatory provisions for reliance, a fast-tracking registration process, and an effective and adapted pharmacovigilance systems.