5 Regulatory Strategy

Development of regulatory strategies for use during public health emergencies requires careful consideration of existing regulatory pathways along with innovations that could be implemented to accelerate medicine, biological or device authorizations and ultimately access.

Some of the most significant innovations available to facilitate authorization are:

• Correlates or Surrogates of Protection

• Standardized Benefit-Risk Assessments

• Platforms

• Collaboration and Convergence Recommendations for Future Public Health Emergencies

A list of additional innovations available to facilitate authorization is provided below:

• Facilitated Regulatory Pathways

• Streamlined Global Regulatory Submission Process during a Public Health Emergency

• Single Package and Label

Once initial authorization is granted, dossiers must be maintained as changes are made. Existing requirements for implementation of changes vary greatly from country to country and a single change could take 4 years or more to be approved in all countries in which a product is authorized. Innovations for the processes to obtain authorization of post approval changes are also needed.

A Regulatory Pandemic Preparedness & Response Dashboard is being created to help give Developers insight into each country’s regulatory readiness for future public health emergencies.