List of National Regulatory Authorities participating in CRP

List of products registered by NRAs through CRP

Appendix 1 A

Appendix 1 B

Appendix 3 B

Appendix 3 C 

Manufacturer's forms

Appendix 2

Appendix 3 A

ePQS –Electronic Prequalification System

An FPP or vaccine product that in all essential features is the same as the prequalified FPP/vaccine is submitted for national registration in a country, the NRA of which, is participating in the collaborative procedure. The countries of NRAs that are currently participating in the Procedure are listed in the Participating Countries side box. Additional NRAs may be invited to participate by WHO if applicants express interest in registering their FPPs or vaccines in countries the NRAs of which are not yet participating in the procedure.

Applicants (generally companies) voluntarily express interest in applying the procedure for accelerated registration to their prequalified products. Applicants authorize WHO to share its assessment and inspection outcomes for the specific product(s), with the NRA(s), of the country in which accelerated registration is sought. An applicant must submit the same dossier as the one approved by WHO for prequalification. The technical part of the dossier should be updated to reflect the data as approved by WHO during prequalification, any WHO-approved variations and requalification. National rules for submission of applications and regulatory fees will apply.

WHO then shares information regarding its evaluation of the FPP for prequalification (i.e. assessment, inspection and product testing/performance evaluation outcomes) with the NRA. The information is shared via a secure internet-based platform, subject to confidentiality undertakings and agreed restrictions on use. Within the NRA, only the designated focal person(s) can access the information.

If the NRA of the country in which registration of the prequalified FPP is sought agrees to apply the procedure to the product concerned, it commits to reaching its decision within 90 days of receiving access to the assessment and inspection information, as to whether it will register the FPP, and to communicate its decision to WHO and the applicant within a further 30 days.

• Shorter time to registration, thereby products can enter the market and be made available to health care providers and patients quickly.
• Less duplication of work for applicants in terms of preparation of dossiers: participating NRAs largely accept submissions already approved by WHO, that is, in the same CTD format as requested by WHO.
• NMRAs save resources since they do not need to carry out a full assessment of the prequalified product or to repeat on site inspection its manufacturing sites.
• Opportunities for work sharing between WHO and NRAs when assessing variations, carrying out follow-up inspections, or organizing sample testing by prequalified quality control laboratories.
• Capacity building at the participating NRAs: prequalification reports (dossier evaluation, inspection reports and test results) are available to staff, providing excellent examples of assessment and inspection carried out to international standards.
• 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).

Any NMRA that would like to participate in the collaborative procedure for accelerated registration should email: 

• a signed and scanned participation agreement (Appendix 1, Part A) 
• a signed confidentiality undertaking (Appendix 1, Part B) for each designated focal point who is to be granted permission to the restricted-access website for the purpose of downloading and uploading information and reports about FPPs that have been submitted for consideration for collaborative registration 

to prequalreg@who.int. The signed originals of the documents should be posted or sent by courier to:

World Health Organization Facilitated Product Introduction Team, Room M431
20 Avenue Appia
1211 Geneva 27
Switzerland.

In order to submit a prequalified FPP for registration in any country, the NRA of which is participating in the procedure, the applicant (usually the manufacturer) should sign and email a consent form (Appendix 2) (one form per country) to prequalreg@who.int. This will serve to grant WHO permission to share its evaluation information with the NMRA. The signed originals of the consent form should be posted or sent by courier to:

World Health Organization
Facilitated Product Introduction Team, Room M431
20 Avenue Appia
1211 Geneva 27
Switzerland

Additionally, the applicant should submit an expression of interest in having the procedure applied to the FPP by completing Appendix 3, Part A and submitting it to the relevant NMRA. It should also email a completed Appendix 3, Part A to prequalreg@who.int.

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 prequalified dossier/data 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.

Quick contact

prequalreg@who.int

kisomas@who.int