WHO to begin development of parallel recommendation and regulatory pathways; shortening the time taken for people to access health products

Ensuring access to quality-assured, safe and effective therapies is a core part of WHO’s mission. This involves two essential services: the development of recommendations on the use of important health products and, independently, their prequalification (PQ) or Emergency Use Listing (EUL). Health products include medicines, vaccines, medical devices including diagnostics and vector control products and may include other products based on future technology developments. Currently, recommendation development and PQ or EUL assessment occur sequentially.

During the pandemic, WHO expedited the recommendation review and EUL of COVID-19 health products as parallel processes. This resulted in listing of the first antivirals several hours after the publication of their recommendations for use.

What was an interim WHO process for the COVID-19 pandemic, will now be adopted for all products with the development of synchronized and parallel, but otherwise entirely independent processes. This will shorten time to access innovative health products in low / low-middle income countries.

Parallel processes will be triggered whenever WHO identifies the need to issue a new or revised recommendation. The target for the dual processes will be to complete both within twelve months from WHO’s initiation of the recommendation development process and formally accepting a manufacturer’s dossier for PQ or EUL assessment. The processes will conclude with a coordinated external communication of their outcome to the manufacturer and Member States.

Vitally, the integrity of the procedure will be maintained as the two processes remain fully independent and respect the confidentiality of manufacturers’ information as appropriate.

This new parallel process will improve access to essential and innovative health products and address inequities in countries that rely on WHO recommendations for the use of these products.

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