There are many regulatory practices and innovations that can facilitate rapid development, emergency use and licensure of biologics, pharmaceuticals, vaccines and devices in response to a public health emergency. Some National Regulatory Authorities (NRAs) have regulations and guidelines that allow use of these practices and innovations, but many do not, which creates a need for a lot of negotiation between each developer and each regulator every time there is a public health emergency, which can take a significant period of time.
Checklist
A checklist that can be used to develop a regulatory readiness dashboard is provided below.
Product Development
Compassionate use/expanded use/special access during clinical trials and/or Emergency Use Authorization with acceleration permitted based on platform experience
Active information sharing and collaboration with other NRAs
Use of a single, harmonized package and label without the requirement for country specific language to be on the physical label (instead available via use of a Q/R code or URL)
Alternatives to randomized, controlled clinical trials, especially where correlates of protection or surrogates of protection have been established for the disease type (e.g. Immunobridging)
Use of a harmonized, streamlined submission process to accelerate data submission, review and approval
Mechanism for developers to meet with regulators to obtain feedback during development
Product Review
WHO maturity level 3 or 4 for vaccines, or a listed/stringent regulatory authority
Accelerated regulatory review
Provisional/conditional approval mechanisms
Regulatory recognition or reliance mechanisms (reliance on all or part of the review completed by a WHO Listed Authority)
Active information sharing and collaboration with other NRAs
Use of a single, harmonized dossier aligned with ICH requirements
Acceptance of a standardized approach to Benefit-Risk modelling
Use of a digital platform for sharing information among regulators
Flexibility to leverage prior knowledge when using platform technologies
Reliance on GMP assessments from trusted regulators
Post Approval/Lifecycle
Use regulatory innovations for initial authorization for post approval changes
Use of Post Approval Change Management Protocols to accelerate implementation of post approval changes
Strong surveillance practices and safety data monitoring to provide rapid feedback following product deployment
Policies and processes for public communication of vaccine safety
Dashboards
The readiness level in each country could be tracked using dashboards to help developers understand overall status of regulatory pandemic preparedness for use in determining which countries can be targeted for acceleration with minimal negotiation needed, as illustrated in Figure 1. Those countries with the highest number of green cells, indicating strong pandemic readiness, could be prioritized.
Figure 1: Regulatory Dashboard - Product Development
Figure 2: Regulatory Dashboard - Product Review
Figure 3: Regulatory Dashboard - Post Approval/Lifecycle
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