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Navigating facilitated regulatory pathways during a disease X pandemic.
Shmona Simpson1, Ajoy Chakrabarti1, David Robinson1
1The Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, WA 98109 USA.
NPJ Vaccines
|October 28, 2020
Summary
Accelerating medical countermeasures for Disease X requires understanding facilitated regulatory pathways. This overview democratizes knowledge on regulatory approaches for faster development and approval, especially in low-income countries.
Area of Science:
- Public Health
- Regulatory Science
- Drug Development
Background:
- Experts convened to accelerate medical countermeasures for Disease X, an unknown pathogen with pandemic potential.
- Efficient navigation of facilitated regulatory pathways is key for timely scientific assessment and approval.
- Stakeholders need accessible knowledge to utilize regulatory pathways during public health emergencies.
Purpose of the Study:
- To provide an overview of facilitated regulatory approaches for medical product assessment.
- To discuss conditions, applicability, and trade-offs of these pathways.
- To address opportunities for developers in low-income countries with developing regulatory frameworks.
Main Methods:
- Review of facilitated regulatory pathways developed by Stringent Regulatory Authorities and the World Health Organization.
- Analysis of conditions and scenarios for pathway utilization.
- Examination of opportunities for developers in low-income countries.
Main Results:
- Facilitated pathways offer opportunities for accelerated development and approval of medical countermeasures.
- Understanding specific pathway requirements and limitations is crucial for effective use.
- Developing regulatory frameworks in low-income countries present unique challenges and opportunities.
Conclusions:
- Democratizing knowledge on facilitated regulatory pathways is essential for global health security.
- Strategic navigation of regulatory pathways can expedite response to emerging infectious diseases.
- Support for developers in low-income countries is vital for equitable access to medical countermeasures.
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