Introduction

The response to recent outbreaks and the COVID-19 pandemic in 2020-2023 drove significant regulatory collaboration and early international agreement on regulatory requirements.  It also led to adoption of accelerated regulatory procedures in many countries and triggered significant regulatory innovations and flexibilities including e.g., rapid approvals of clinical trial applications, real-time scientific advice and protocol review procedures, flexible approaches to GMP inspections, expedited and rolling reviews of license applications and in many cases, work sharing and increasing use of reliance for regulatory reviews across regions.   

The basic tenet of regulations for healthcare products, regardless of their jurisdiction, includes the assurance that the medicines, vaccines and devices released for use are manufactured with clearly defined quality standards and are demonstrated to be safe and efficacious. Mindfulness of changes in viruses, and hence therapeutics and vaccines, is needed to ensure a favorable benefit-risk assessment, particularly in light of the new therapeutics and vaccines that become available over time. In normal situations, timely access to medical products relies on traditionally established regulatory paradigms, preparing for health emergencies demands additional approaches, again based on benefit-risk assessments. It requires planning and measures beyond the established paradigm to ensure quick access to medicines, vaccines and devices during such crises. 

The following information is provided in that spirit. Public health emergencies (PHEs) should not be met with just quicker business as usual, there need to be innovations added to the regulatory ecosystem to ensure the quickest access to lifesaving medicines, biologics, vaccines and devices guarantying high quality and safety standards. These innovations should be evaluated in “peacetime” and supportive data generated to enable their use and deployment with speed at the time of a pandemic. 

This Pandemic Preparedness and Response Regulatory Playbook is being prepared in “peacetime”, or outside of a PHE, and can be used whenever it is needed.  It will be most helpful to developers who are looking for ways to accelerate the regulatory processes needed to enable patient access to medical countermeasures addressing PHEs.  It may also be useful for regulators and others to use for sharing best practices and for anyone who is interested in understanding how the regulatory ecosystem works.