The availability of quality-assured in vitro diagnostics (IVDs) is a core element of a functional healthcare system. National regulatory and product selection processes have been identified as one of the barriers slowing down access to priority quality assured IVDs in many WHO Member States. Although WHO prequalified IVDs are assessed according to international standards, unclear pre-market registration processes, repetitive performance evaluations and lengthy product selection procedures result in a delayed market entry of products which have been assessed and found compliant with WHO prequalification requirements. WHO is committed to supporting National Regulatory Authorities in optimizing available resources, applying reliance principles where possible, and facilitating access to quality assured health products.

WHO Collaborative Procedure: aims and principles

WHO launched its collaborative procedure for accelerated registration of prequalified finished pharmaceutical products (FPPs) in 2013. It accelerates registration through improved information sharing between WHO prequalification and national regulatory authorities (NRAs). By leveraging assessment and inspection outputs already produced by WHO prequalification, and thereby eliminating duplicative regulatory work, it speeds up in-country registration of quality-assured products and contributes to their wider availability. (A similar procedure, for accelerated registration of FPPs that have been approved by stringent regulatory authorities is now also in operation.)

The key principles of the collaborative procedure for FPPs is that it is:

• voluntary: A manufacturer of a prequalified product(s) voluntarily expresses interest in applying the procedure to facilitate in-country registration of its product(s) in specific countries.
• confidential: The NRA signs a participation agreement and confidentiality undertaking with WHO, whereby it adheres to the provisions of the procedure. Only countries with a signed agreement with WHO can participate in the procedure. The manufacturer, through written consent, authorizes WHO to share prequalification assessment reports for the specific product(s) with the NRAs of countries in which accelerated registration is sought.
• based on product sameness: A manufacturer must submit the same product version as the one prequalified or stringently approved to countries where application of the collaborative procedure is sought. Product sameness is a mandatory prerequisite for applying of a collaborative procedure.

Process and impact

Based on the agreement between WHO and the NRA(s), WHO shares confidential prequalification assessment reports (product dossier assessment report, performance evaluation report, and manufacturing site(s) inspection report) with the NRA(s) of the country(ies) in which the manufacturer wishes to market its product. The information is shared via a secure internet-based platform, subject to confidentiality undertakings, and agreed restrictions on use.

The NRA(s) follows its (their) internal procedures when using WHO confidential and public reports, in addition to the data submitted by the manufacturer directly to the NRA(s). WHO prequalification does not interfere with the national decision-making. At a minimum, an NRA verifies sameness of the product submitted for registration and the prequalified product to make its registration decision. In countries where the procedure is well established, the NRA commits to taking a registration decision within 90 days from receipt of the full information package (manufacturer'’s submission and all prequalification reports). In case of a suspension or delisting of the prequalified product, WHO alerts all NRAs which registered the respective product based on the collaborative procedure.

Effective application of the collaborative procedure contributes to shorter time to national registration, optimization of limited pre-market registration resources, and product traceability and transparency for buyers given the verified sameness between the prequalified product and the product registered at national level.

Collaborative procedure pilot for IVDs

A one-year pilot project aiming at introducing the collaborative procedure for in vitro diagnostics (IVDs) started in Q3 2019. Five countries were selected to participate in the pilot project: Cameroon; Côte d’Ivoire; Ethiopia; Nigeria; the United Republic of Tanzania.

Three of the five countries participating in the pilot CRP project were able to register a prequalified IVD within a shorter timeframe than would normally be the case. Additionally, the pilot project encouraged participants to review their current national registration procedures for IVDs, bringing a clearer understanding of the regulatory burden and duplication of existing processes that they may entail. Blockages to the registration of IVDs, and opportunities for optimizing the collaborative procedure at country level, were identified.

Lessons learned from the pilot project have been used to develop the draft document Guidelines for collaborative procedure between the World Health Organization (WHO) and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified in vitro diagnostics, which is now being finalized.

The collaborative procedure has the potential to contribute to improved access to priority IVDs of assured quality, safety, and performance. WHO will assess the information gathered throughout the pilot project to assist Member States in optimizing regulatory processes to better support timely access to quality assured IVDs.