Revised Quality Assurance Policies for Pharmaceuticals and Medical Devices (including In Vitro Diagnostics) and Core Personal Protective Equipment
24 January 2024
Revised Quality Assurance Policies for Pharmaceuticals and Medical Devices (including In Vitro Diagnostics) and Core Personal Protective Equipment
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To respond to the changing regulatory environment and enhance equitable access to quality assured health products, the Global Fund has updated its Quality Assurance Policy for Pharmaceuticals [ download in English | Español | Français ] and Quality Assurance Policy for Medical Devices (including In Vitro Diagnostics) and Core Personal Protective Equipment [ download in English | Español | Français ] . The latter, replacing the original Quality Assurance Policy for Diagnostics, has been expanded to include additional medical devices such as core personal protective equipment (PPE) and condoms.
Countries can refer to this document [ download in English ] for guidance on the updates to the two policies and their implications. These amendments, approved by the Global Fund Board on 15 November 2023:
- Align with the evolving procurement landscape and the Global Fund Strategy (2023 - 2028).
- Reflect the World Health Organization-listed Authority initiative to enable procurement from additional regulatory authorities globally.
- Formalize the Emergency Use Pathway. This mechanism, used during the COVID-19 response, is essential for purchasing health products in a pandemic.
- Ensure alignment of requirements across product categories to improve coherence and compliance. Inconsistencies between the quality assurance policies have also been removed.
In case of any discrepancies between the PSM Guide or other operational guidance and the Quality Assurance Policies, the Quality Assurance Policies shall prevail.