Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

SF Medical Products – Background

Globalization of the market in active pharmaceutical Ingredients and finished medical products brings with it the urgent need for effective International collaboration, cooperation and coordination to ensure global access to safe, quality, efficacious and affordable medical products.

Medical products can be manufactured in one part of the world, packaged in another and supplied to a third. An inter-regional surveillance and monitoring system is now key in protecting patients and health systems worldwide from SF medical products.

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The exponential increase to internet connectivity and mobile telecommunications has opened up a global market place for suppliers and consumers of medical products.

Thoroughly understanding the global threat posed from SF medical products to better inform Member States in preventing them from reaching patients, detecting them quickly when they have penetrated the supply chains and responding to them proportionately and consistently are the key elements of capacity building and regulatory strengthening at a national and regional level.

WHO will continue to conduct a range of activities with Member States and stakeholders to minimize the risks from SF medical products, including developing policy, identify good practice, data collection and analysis and issuing alerts, to better inform decision making in investing to secure supply chains and build regulatory capacity.