Health products regulation and prequalification

Health products regulation and prequalification

Learning Catalogue

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Effective regulatory systems are essential components of well-functioning health systems and contribute significantly to universal health coverage and improved public health outcomes.

Despite notable progress in the development of national regulatory systems over the past decades, more than 70% of Member States still lack a regulatory system operating at an advanced level of performance (maturity level 3 or 4). One of the main challenges in low- and middle-income country (LMIC) regulatory systems is a shortage of skilled regulatory personnel.

Advancements in science and technology – such as biotechnological products, gene therapy and artificial intelligence in diagnostics – alongside the globalization of supply chains and the increasing scale of health products in LMICs, underscores the urgent need for continuous training and education of the regulatory workforce. This ensures independent, scientifically robust oversight of health products.

Ineffective, poor quality, substandard and falsified products have severe public health consequences, deplete already limited resources and erode public trust in health systems. By contrast, effective and efficient regulatory systems with a skilled workforce protect the public, facilitate timely access to quality products and encourage innovation.

Since the adoption of the World Health Assembly resolution WHA67.20 on regulatory system strengthening in 2014, WHO has developed a wide range of learning opportunities for regulators, policy-makers and public health specialists. These cover various regulatory functions and product-specific considerations, utilizing diverse training methods such as self-paced e‑learning, instructor-led training, and on-the-job training.

This webpage consolidates all learning opportunities offered by the WHO Regulation and Prequalification Department. Prospective learners can explore the categories below to find courses that meet their needs.

 

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