WHA67.20 - Regulatory System Strengthening for Medical Products. WHA resolution; Sixty-seventh World Health Assembly, 2014 (Arabic version)
(2014; 5 pages) [Chinese] [English] [French] [Russian] [Spanish]

Abstract

REQUESTS the Director-General:

  1. to continue to support Member States upon their request in the area of regulatory system strengthening, including, as appropriate, by continuing to:
    • evaluate national regulatory systems;
    • apply WHO evaluation tools;
    • generate and analyse evidence of regulatory system performance;
    • facilitate the formulation and implementation of institutional development plans; and
    • provide technical support to national regulatory authorities and governments;
  2. to continue to develop appropriate norms, standards and guidelines, including taking into account national, regional and international needs and initiatives, in accordance with WHO principles;
  3. to ensure that all relevant parts of the Organization, at all levels, are actively engaged and coordinated in the carrying out of WHO’s mandate pertaining to regulatory system strengthening as an integrated part of health system development, recognizing that WHO’s support in this critical area, particularly for developing countries, may be required, as appropriate, well into the future;
  4. to prioritize support for establishing and strengthening regional and subregional networks of regulatory authorities, as appropriate, including strengthening areas of regulation of healthproducts that are the least developed, such as regulation of medical devices, including diagnostics;
  5. to promote the greater participation of Member States in existing international and regional initiatives for collaboration and cooperation in accordance with WHO principles and guidelines;
  6. to strengthen WHO’s prequalification programme, including its integration and coherence, taking into account the needs and capacities of national and regional regulatory systems to assist in ensuring a supply of quality, safe, efficacious and affordable medical products;
  7. to support the building-up of effective national and regional regulatory bodies and networks;
  8. to increase support for and recognition of the significant role of the International Conference of Drug Regulatory Authorities in promoting the exchange of information and collaborative approaches among drug regulatory authorities, and as a resource to facilitate further development of regulatory cooperation and coherence;
  9. to raise awareness of the importance of effective regulatory systems within the health system context;
  10. to increase support and guidance for strengthening the capacity to regulate increasingly complex biological products with the focus on biotherapeutic products, blood products and associated in vitro diagnostics, and, where appropriate, on new medicines for human use based on gene therapy, somatic-cell therapy and tissue engineering;
  11. to ensure that any activity carried out under this resolution does not duplicate or circumvent the work plan and mandate of the Member States mechanism on substandard/ spurious/falsely-labelled/falsified/counterfeit medical products;
  12. to report to the Seventieth and Seventy-second World Health Assemblies on progress in the implementation of this resolution.
 
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