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1 results

  • 2 - The Vaccine Development Ecosystem

  • Ana Santos Rutschman, Villanova University, Pennsylvania
  • Book:
    Vaccines as Technology
    Published online:
    07 April 2022
    Print publication:
    14 April 2022, pp 26-55

  • Summary

    As vaccines are complex technologies that interact with the human body, their development is overseen by regulators in the administrative state. Countries structure the review of pharmaceutical products according to domestic rules and institutional design. As such, vaccines are reviewed as biologic products by regulatory authorities at the domestic level, such as the Therapeutic Goods Administration in Australia or the Pharmaceutical and Medical Devices Agency in Japan. The national basis of vaccine regulation inevitably leads to country-specific processes and timelines and may in some cases lead to different decisions.