The World Health Organization (WHO) has recently published new guidance for the use of the WHO Collaborative registration procedure for WHO-prequalified in vitro diagnostics in the WHO Technical Report Series (TRS) 1030, 2021 (Annex 4) 1. This procedure is a great tool for national regulatory authorities (NRAs) wishing to enhance their pre-marketing and post-registration evaluation and registration of in vitro diagnostics by relying on the WHO prequalification outcomes.
The collaborative procedure for prequalified in vitro diagnostics was developed on the basis of experience with procedures for prequalified medicines and vaccines. It was piloted successfully in 2019 and is now ready for rollout.
The procedure facilitates and accelerates national registration of WHO-prequalified in vitro diagnostics through sharing of confidential information between WHO and participating NRAs at the manufacturer’s request. Confidential information that is shared by WHO includes assessment, inspection, and performance evaluation outcomes for the WHO-prequalified diagnostics. Of greatest interest to manufacturers and other stakeholders, including the general public, is that application of the procedure enables faster registration and use of health products meeting WHO-recommended standards. The COVID – 19 pandemic has highlighted and reinforced the need for quick access to quality-assured diagnostics.
The collaborative procedure for in vitro diagnostics incorporates elements of capacity building and regulatory harmonization. Successful application of the procedures is highly dependent on the ability and willingness of manufacturers (the applicants), regulatory authorities, and WHO to work together to meet public health goals. In vitro diagnostics that have been prequalified by WHO undergo thorough evaluation (dossier assessment and laboratory performance evaluation) and quality audit of the manufacturing facilities according to international standards to confirm their quality, safety, and performance. Such products need to be approved for use by the NRAs of the countries for which market entry is sought. Repeating assessment, performance evaluation, and quality audits of those products consumes scarce regulatory resources and unnecessarily prolongs the issuance of market authorization and the time needed to make them available to patients.
It is expected that Member States will take advantage of the opportunity provided through the collaborative registration procedure to facilitate in-country registration of WHO prequalified in vitro diagnostics.