Briefing Note: Revised Quality Assurance Policies for Pharmaceutical Products, and

The QA Policies introduced a number of changes, including the recognition of WHO-listed authorities (WLA), the use of the WHO Emergency Use Listing procedures or other emergency procedures set up by a Stringent Regulatory Authority (SRA) or WLA, and the risk-based approach the Global Fund will take for handling quality-related concerns that have been identified on specific orders. [...] The principles of the duration of the transitional provisions are articulated in Section 29 of the QA Policy for Medical Devices (including In Vitro Diagnostics) and Core Personal Protective Equipment to allow for continuous procurement and to maintain access. [...] Additionally, the Global Fund uses its best efforts to communicate the new QA requirements and provide training as well as the possibility of a direct line of communication to address questions from partners. [...] Page 3 of 6 Updates to the QA Policy for Pharmaceuticals Regulatory requirements • Any marketing authorization issued by the WLA after the date of listing as a WLA is eligible under the new QA Policy. [...] At the time of the creation of the GHTF, the United Kingdom was a member state of the European Union and is thus also a founding member and continues to be recognized by the QA Policies as such.