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WHO Unveils Pilot for Prequalification of Human Insulin Products

March 4, 2020

The World Health Organization (WHO) has launched a pilot program aimed at increasing insulin access by prequalifying biotherapeutic products that contain human insulin as an active ingredient.

The prequalification program — initially set up in 2001 to increase access to products for HIV/AIDS, malaria and tuberculosis — aims to increase the supply of insulin products to countries with limited access to quality medicines.

The WHO is inviting manufacturers to flag their interest in submitting human insulins that are already approved by a national regulatory authority for marketing in a specific country. The products will be assessed for prequalification using an abridged procedure if they have been approved by a “stringent regulatory authority.”

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