Collaborative registration procedure for prequalified in vitro diagnostics
/regulation-and-prequalification-(rpq)/regulation-and-safety-(reg)/dsc_3739.jpg?sfvrsn=d4af6936_9 "A laboratory technician at work at Afrigen in Cape Town, South Africa")
WHO prequalifies in-vitro diagnostics to guide procurement by the United Nations agencies and other international organizations for supply to low-income countries. Additionally, the prequalification outputs and outcomes are utilized by NRAs to facilitate national decisions for marketing authorizations. This procedure facilitates sharing, at the manufacturer’s request, of non-publicly available PQT assessment audit and performance evaluation report with participating NRAs.
The product submitted for national registration must be the same in all essential features as the prequalified product, and the documents that are being shared must be relevant to the product being proposed for marketing in the local country. The national rules for submission of applications and regulatory fees apply when this procedure is used.
Aim: WHO launched the Collaborative Registration Procedure (CRP) for in vitro diagnostics in 2019 following a successful implementation of a Pilot. The CRP for WHO prequalified IVDs aims to accelerate registration through improved information sharing between the WHO Prequalification and national regulatory authorities (NRAs). The CRP builds on the collaboration between WHO, national regulatory authorities (NRAs), and manufacturers, by leveraging the work of WHO prequalification, and hence reducing duplication of work, facilitating in-country registration of quality assured products and making these products more widely available.
Principles:
• Voluntary: Under the CRP, manufacturers of prequalified products voluntarily express interest in applying the procedure to facilitate in-country registration of their product(s) in specific countries.
• Confidentiality: The NRAs sign a participation agreement and confidentiality undertaking with WHO, whereby they adhere to the provisions of the procedure. Only countries with a signed agreement with WHO can participate in the CRP. 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.
• Product sameness: The manufacturer must submit the same product version as the one prequalified to countries where the CRP is applied. Product sameness is a mandatory pre-requisite for applying the CRP.
How can NRAs apply to participate?
Any NRA intends participate in the collaborative procedure for accelerated registration should email electronic copies of the following documents to prequalreg@who.int.
How can a manufacturer be engaged to participate in CRP?
The applicant (usually the manufacturer) should sign and email a consent form (Appendix 2) (one form per country) to prequalreg@who.int granting WHO permission to share its assessment outcome with the NRA. Additionally, the applicant is required to submit an expression of interest to confirm interest to participatell in CRP for IVDs.
All
the
signed original
forms
should be sent
by courier to:
World
Health Organization
Facilitated
Product Introduction Team, Room M431
20
Avenue Appia
1211
Geneva 27
Switzerland
The expression of interest (Appendix 3, Part A) should be submitted to the NRA in addition to the national registration documents it requires (and irrespective of whether the application is new or pending).
Any differences between the dossier/data of a prequalified product and the national submission should be stated as requested by Appendix 3, Part A. When a request is made for application of the procedure to a pending registration submission, the advice of the NRA should be sought before submission.
How long does it take?
If the NRA of the country in which the registration of a prequalified in vitro diagnostics is submitted agrees to apply the procedure to the product concerned, it commits to reaching its decision within 90 working days since it receives access to all relevant information, and to register the FPP, communicating its decision to WHO and applicant (Appendix 9) within a further 90 working days.
What are the benefits of the procedure?
- Shorter registration timeline, resulting into quick market and availability to health care providers and patients;
- Minimal duplication of work for applicants in terms during compilation of technical data;
- NRAs save resources i.e. human and financial since they do not need to repeat assessments of the prequalified product and onsite inspection;
- Opportunities for work sharing between WHO and NRAs when assessing variations, carrying out follow-up audits, and evaluation of samples;
- Capacity building of the participating NRA staff: prequalification reports (dossier evaluation, audit reports and performance evaluation;
- Transparency for buyers: products registered through the collaborative procedure are in all essential features the same as the related WHO-prequalified products and are, in effect, regulated by both WHO and the relevant NMRA(s).