Regulating medical products - World Health Organization (WHO) MedicinesWHO plays a vital role in the regulation of medical products At the global level, WHO works to develop internationally recognized norms, standards and guidelines for medicine quality, safety and efficacy At the country level, WHO provides guidance, technical assistance and training to enable countries to implement these guidelines in the context of their own specific regulatory
Substandard and falsified medical products - World Health Organization . . . These products can be found in all countries, impacting all types of medical products, including life-saving treatments like vaccines, antibiotics and cancer therapies In 2017, the World Health Organization estimated that 1 in 10 medicines in low- and middle-income countries failed quality control tests, suggesting the product is substandard or falsified This can lead to serious health risks
Health products policy and standards - World Health Organization (WHO) Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other piece of medical equipment Medical equipment excludes implantable, disposable or single-use medical devices
Substandard and falsified medical products - World Health Organization . . . Substandard and falsified medical products create many problems for both the individual taking the medicine and for families, the larger society, health care system and supply chain When medicines do not work the way they should, they can fail to treat or prevent disease, contribute to antimicrobial resistance, waste precious resources and lead to a loss of confidence in medicines and
Largest number of regulatory agencies for medical products approved as . . . “This crucial expansion of the WLA framework is a transformative milestone in the global public health regulatory landscape,” said Dr Yukiko Nakatani, Assistant Director-General, Access to Medicines and Health Products and Assistant Director-General, Antimicrobial Resistance ad interim “As WLAs, these agencies can be relied on to reassure quality and safety of medicines and vaccines to
Medical Product Alert N°3 2025: Falsified IMFINZI (durvalumab . . . Alert SummaryThis WHO Medical Product Alert refers to three batches of falsified IMFINZI (durvalumab) injection 500mg 10ml The falsified products have been detected in the Islamic Republic of Iran and Türkiye These falsified products were reported to WHO in March 2025 WHO previously issued Medical Product Alert N°5 2024 regarding another falsified batch of IMFINZI that was detected in
Access to Medicines and Health Products - World Health Organization (WHO) Countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs of essential medicines, especially for noncommunicable diseases, and the growing problem of substandard and falsified medical products entering the global supply chain Added to this, there are other challenges to ensuring
Health products policy and standards - World Health Organization (WHO) TRS 1025 - Annex 7: Good storage and distribution practices for medical products 20 April 2022 TRS 1044 - Annex 8: Points to consider for setting the remaining shelf-life of medical products upon delivery TRS 1044 - Annex 8: Points to consider for setting the remaining shelf-life of medical products upon delivery
Regulation and Prequalification - World Health Organization (WHO) The WHO Collaborative Registration Procedure (CRP) is a reliance and collaboration mechanism to facilitate and accelerate the assessment and registration of medical products in participating countries Through CRP, National Regulatory Authorities (NRAs) can access product assessment reports from stringent regulatory authorities (SRAs) or WHO Prequalification, allowing for a faster
Regulation and Prequalification - World Health Organization (WHO) Providing guidance and support to WHO Member States and facilitate collaboration among various stakeholders regarding the regulation of medical products across their lifecycle Regulation and Safety priorities are based on a strategic plan entitled “ Delivering quality-assured medical products for all 2019-2023: WHO's five-year plan to help build effective and efficient regulatory systems ”