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What is WHO Prequalification (WHO PO) Status
31 Jul 2024

What is WHO Prequalification (WHO PO) Status?

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It is a quality assurance process managed by the World Health Organization (WHO) that assesses the quality, safety, and efficacy of medical products, including medicines, vaccines, diagnostics, and medical devices. Products that meet WHO standards receive prequalification, indicating they are acceptable for procurement by United Nations agencies and other large-scale buyers.

Benefits for WHO Prequalification (WHO PO) status

WHO Prequalification status is a critical certification that ensures medical products meet high standards of quality, safety, and efficacy. It facilitates global market access, regulatory approval, and contributes significantly to public health, particularly in low- and middle-income countries. Manufacturers aiming for WHO PQ status must navigate a rigorous process but stand to gain substantial benefits in terms of marketability, reputation, and global health impact.

  • Increased Market Access: WHO PQ status opens doors to large-scale procurement opportunities by international agencies and health programs.
  • Regulatory Facilitation: National regulatory authorities often expedite their approval processes for WHO-prequalified products.
  • Enhanced Reputation: Prequalification status is a mark of quality that can enhance the reputation and marketability of a product.
  • Contribution to Global Health: By ensuring high-quality products are available in resource-limited settings, manufacturers contribute to improved global health outcomes.

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