WHA67.21 - Access to Biotherapeutic Products Including Similar Biotherapeutic Products and Ensuring Their Quality, Safety and Efficacy. WHA Resolution; Sixty-seventh World Health Assembly, 2014
(2014; 3 pages) [Arabic] [Chinese] [French] [Russian] [Spanish]

Resumen

REQUESTS the Director-General:

  1. to support Member States in strengthening their capacity in the area of the health regulation of biotherapeutic products, including similar biotherapeutic products;
  2. to support, as appropriate, the development of national regulatory frameworks that promote access to quality, safe, efficacious and affordable biotherapeutic products, including similar biotherapeutic products;
  3. to encourage and promote cooperation and exchange of information, as appropriate, among Member States in relation to biotherapeutic products, including similar biotherapeutic products;
  4. to convene the WHO Expert Committee on Biological Standardization to update the 2009 guidelines, taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities and to report on the update to the Executive Board;
  5. to report to the Sixty-ninth World Health Assembly on progress in the implementation of this resolution.
 
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