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Research, Development and Regulatory Approval

person putting a drop on test tube

Research, Development and Regulatory Approval

Understand how life-saving interventions must complete rigorous processes to ensure their safety and ethical use, and receive approval for marketing and distribution within a country.

  • National Institutes of Health - Global Clinical Research Regulations
  • European Medicines Agency - EU-M4all: Promoting medicines and vaccines for low and middle-income countries
  • WHO Collaborative Registration Procedure
  • WHO Emergency Use Listing for Vaccines
  • WHO Emergency Use Listing for In Vitro Diagnostics
  • WHO Prequalification (PQ) - Medicines
  • WHO Prequalification (PQ) - In Vitro Diagnostics
  • WHO Prequalification (PQ) - Vaccines
  • WHO Prequalification (PQ) - Vector Control
  • The National Academies of Science, Engineering, and Medicine - 2020 Report on Stronger Food and Drug Regulatory Systems Abroad
  • US Food and Drug Administration - Medical Devices
  • US Food and Drug Administration - Information for Industry | Drug

About Us

The Launch and Scale Speedometer is led by the Duke Global Health Innovation Center, with support from the Bill & Melinda Gates Foundation.

See our other partners and funders at dukeghic.org/partners.

Duke Global Health Innovation Center

Contact Us

Duke Global Health Innovation Center

Office: 710 West Main Street, Suite 200,
Durham, NC, 27701 USA
Email: dukeghic@duke.edu
Web: www.dukeghic.org

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