Snapshot

The Parallel recommendation and regulatory pathway pathway has been developed by the of WHO.

This pathway can be used where Finished Pharmaceutical Products (FPPs) for treating HIV/AIDS, TB, malaria, neglected tropical diseases, diarrhoea, influenza, COVID-19 or for reproductive health, and APIs used in the production of these FPPs..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

WHO should apply parallel rather than the current sequential processes in its prequalification and development of recommendations. The parallel process will be initiated once the scientific relevance and need are agreed between the WHO departments responsible for issuing recommendations on health products, SCI and RPQ: (a) a product is deemed eligible for prequalification pursuant to and in accordance with the relevant prequalification procedure; and (b) the director of the WHO department responsible for issuing recommendations on use issues a formal memo to request a parallel process, and the RPQ and QNS Directors accept. The parallel assessment process and timeline commences once: (a) RPQ has received and formally accepted a complete dossier for assessment from the manufacturer, and (b) The WHO department responsible for issuing recommendations on use has received (access to) the data package and decided, based on its completeness, to proceed with recommendation development (including interim recommendations and the principle of living guidelines). The parallel process will be completed once the assessments result in a decision on publishing the recommendation and/or a prequalification decision. Whilst these processes run in parallel, they will remain independent from each other in reaching their conclusion(s). Subject to resource availability, the parallel assessment process should take no more than twelve months from commencement to completion (decisions on publication and/or prequalification). This twelve-month timeframe aligns with the timeframes agreed by NRAs and other relevant competent authorities worldwide on the assessment pathways of health products. Notwithstanding this, RPQ will continue to adhere to its procedural timeframes for each product stream, which are all under twelve months.