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WHO released its 11th Invitation to manufacturers of APIs to submit an Expression of Interest (EOI) to the WHO Prequalification Team for evaluation. The prequalification programme aims to make quality priority medicines available for the benefit of those in need, in support of “national and global efforts to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health.” If evaluation demonstrates that an API and its corresponding manufacturing site(s) meet WHO standards, the API will be included in WHO’s list of those acceptable for incorporation into finished pharmaceutical products.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
