The World Health Organization

Ambitious—and essential

Founded in 1948 and headquartered in Geneva, Switzerland, the World Health Organization (WHO) works across 150 countries in a concerted mission to “promote health, keep the world safe, and serve the vulnerable."

A designated United Nations Specialized Agency, WHO’s multi-pronged approach focuses primarily on a few key aspects of global health promotion:

• Universal health coverage
  • Improved access to essential services, medicines and health products
  • Sustainable financing
  • Health career training
  • Policy advice
  • Improved information exchange

• Addressing health emergencies
  • Preparation and risk management
  • Prevention and outbreak containment
  • Fast detection and response
  • Health support delivery in challenging settings

• Worldwide maintenance of health and well-being
  • Prioritizing health in all state policy
  • Researching social determinants of disease
  • Mental health promotion
  • Noncommunicable disease prevention
  • Addressing antimicrobial resistance
  • Eradication of high-impact communicable diseases

Regulating the regulators

WHO’s efforts to coordinate international movement toward these goals has evolved over time. The Stringent Regulatory Authority (SRA) designation was established for qualifying national regulatory entities in 2008, redefined in 2015, and most recently superseded in 2019 with the creation of WHO-Listed Authorities (WLA).

The chief purpose of WHO’s newest WLA designation is to recognize and support the efforts of high-performing regulatory authorities to provide access and supply of safe, effective medicines and vaccines.

WLA status is conferred only upon those member-state entities that request the designation themselves and meet “maturity level 3” requirements (as defined by the WHO Global Benchmarking Tool). For manufacturing processes, maturity level 3 criteria include:

• Adoption of standards, process descriptions and procedures that are tailored to specific development projects
• Consistency of tailored projects, wherever possible, with the organization’s existing set of more standard processes
• Process descriptions more rigorous than at lower maturity levels
• Proactive project management, involving detailed measures of the process, its work products and services

Building global trust

For WHO, the overarching goal in identifying and working with WLAs is one of international cooperation and “reliance” — a term increasingly used to describe information sharing and regulatory decision-making among trusted agencies around the globe. While yet unstandardized approaches, national borders and political concerns remain obstacles to greater success, increased inter-reliance becomes an especially critical tool during the present Covid-19 pandemic.

In this way, the World Health Organization seeks to streamline regulation of vaccine research, development and delivery, while minimizing redundancy and waste of limited regulatory and financial resources.