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Related Experiment Videos

Regulatory pathways for vaccines for developing countries.

Julie Milstien1, Lahouari Belgharbi

  • 1Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland. juliemilstien@yahoo.com

Bulletin of the World Health Organization
|March 26, 2004
PubMed
Summary

Regulatory pathways for vaccines in developing nations are complex. No single solution fully addresses challenges, necessitating infrastructure development and international collaboration for vaccine accessibility.

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Area of Science:

  • Public Health
  • Vaccinology
  • Regulatory Science

Background:

  • Vaccines developed exclusively for developing countries encounter significant regulatory obstacles.
  • Existing regulatory frameworks are often jurisdiction-specific and may not accommodate products for global health needs.
  • Perceived weaknesses in regulatory authorities in developing nations add to these challenges.

Purpose of the Study:

  • To identify and evaluate potential regulatory pathways for vaccines intended for developing countries.
  • To assess these pathways against key criteria ensuring product safety, efficacy, and accessibility.
  • To highlight areas for improvement in global regulatory harmonization for essential medicines.

Main Methods:

  • Identification of several regulatory pathway options, including in-country licensing, centralized review, and third-party approvals.

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  • Evaluation of these options based on criteria such as regulatory function assurance, epidemiological assessment, manufacturer risk, and regulatory feasibility.
  • Analysis of the need for strengthening national regulatory infrastructures and legislative frameworks.

    • Main Results:

    • No single evaluated regulatory pathway comprehensively meets all essential criteria for vaccines in developing countries.
    • Development of national regulatory infrastructures, including legislative frameworks for evidence-based policy, is crucial for all pathways.
    • The World Health Organization (WHO) has initiated efforts to build regulatory capacity with some success.

    Conclusions:

    • Addressing regulatory hurdles for developing-country vaccines requires a multifaceted approach, as no single pathway is universally optimal.
    • Substantial investment in and development of national regulatory capacities are essential.
    • Continued international cooperation and targeted actions are needed to ensure the availability of vital vaccines for global health.