How the concept of WHO-listed authorities will change international procurement policies for medicines

Collaborative partnerships as a solution for poor access to essential antimicrobial medicines: what can we learn from the chlorhexidine gel example?

“…1 Major importers, including UN agencies and international NGOs, prioritise products with WHO prequalification or approval by SRAs (to be replaced in the long-term by 'WHO-listed authority' (WLA)). 5 Alignment and collaboration between WHO, SRA (WLAs) and national regulatory authorities (NRAs) are essential to facilitate transparent and efficient registration processes and postmarketing surveillance, both at national and supranational level. A good example is represented by the WHO Collaborative Procedure for Accelerated Registration.…”

“…A good example is represented by the WHO Collaborative Procedure for Accelerated Registration. 5 Furthermore, regional harmonised regulatory systems enable streamlining the registration process. In particular, the East African Community Medicines Regulation Harmonisation (EAC MRH) Programme will likely facilitate similar access initiatives, expanded at a regional level.…”

“…This is likely due to reluctancy to engage in burdensome registration processes with relatively small and unclear financial return, related to small market sizes, poor pharmaceutical budgets and unpredictable demand—resulting from high out-of-pocket expenditures, absence of or non-compliance with guidelines and lack of microbiological surveillance data 1. Major importers, including UN agencies and international NGOs, prioritise products with WHO prequalification or approval by SRAs (to be replaced in the long-term by ‘WHO-listed authority’ (WLA)) 5. Alignment and collaboration between WHO, SRA (WLAs) and national regulatory authorities (NRAs) are essential to facilitate transparent and efficient registration processes and postmarketing surveillance, both at national and supranational level.…”

“…Alignment and collaboration between WHO, SRA (WLAs) and national regulatory authorities (NRAs) are essential to facilitate transparent and efficient registration processes and postmarketing surveillance, both at national and supranational level. A good example is represented by the WHO Collaborative Procedure for Accelerated Registration 5. Furthermore, regional harmonised regulatory systems enable streamlining the registration process.…”

“…However, technology transfer should be accompanied by regulatory strengthening. Therefore, NRAs should be included in any future access collaborative partnerships, whether national or supranational, to ensure sustained compliance with WHO Good Manufacturing Practices and with adequate quality specifications,5 7 for example, correct chlorhexidine concentration,8 or water of adequate quality to avoid contamination with Gram-negative bacteria 9. The latter is particularly important for chlorhexidine.…”