The regulatory approval of medical products in countries can be lengthy, which often compromises patients’ timely access to much-needed safe, effective and quality-assured medicines. Applying regulatory reliance to finished pharmaceutical products (FPP) that have been assessed by a recognized regulatory authority (such as stringent regulatory authorities (SRA)), allows an authority to leverage the work performed by other authorities. This reduces duplication of regulatory efforts, resources and time, while maintaining national sovereignty. The SRA CRP uses the regulatory expertise of SRAs to simplify the product evaluation and approvals processes for other Regulatory authorities, accelerating the access to priority products by patients. It applies to any FPP (innovative medicines, vaccines, and biotherapeutics, as well as generics and similar biotherapeutics), as far as the product has been previously assessed and/or approved by an SRA and where a positive scientific opinion (including EU-M4all opinions) exists and can be shared with other NRAs worldwide. Like the procedure for prequalified products, this procedure facilitates the sharing of non-publicly available assessment, and inspection reports, from participating “SRA” and interested NRAs. 

Participation is open to any interested NRA or pharmaceutical company, and the procedure is designed to be applicable to any SRA-approved FPP (innovator or generic). The pharmaceutical company (applicant) submits an FPP for registration that is the "same" (as defined by the procedure) as the SRA-approved product, to participating NRAs. In the case of deviations from the SRA-approved product, these must be specified by the applicant. The product dossier must be organized in the common technical document format (CTD) that was approved by the SRA and adapted for the purpose of the procedure. The applicant or WHO – with the agreement of the relevant SRA – will share the full assessment and GMP inspection reports for the FPP with the participating NRAs, as well as additional data documenting potential deviations from the FPP approved by the SRA.

The role of the SRA will be to data authentication, and, when specifically agreed with individual SRAs, provision of additional explanation of their decisions, should either or both be requested by the NRAs. Participating NRAs will use the data submitted to support their decision-making regarding registration (using recognition or abridged review pathways for product assessment). They will seek to issue an "accelerated" decision on registration within 90 working days from the moment they receive all relevant documents. The procedure will not interfere with their national, regulatory decision-making processes, or with national legislation, or with levying of regulatory fees. Similarly, it will be the NMRAs responsibility to reach agreement with applicants regarding specific risk-management plans and pharmacovigilance follow-up. Management of SRA-approved post-registration variations will follow principles similar to those applied under registration. WHO’s role will be to facilitate cooperation, communication and information exchange among applicants, participating NRAs and SRAs.

Pharmaceutical companies may participate if they:

NRAs may participate by:

a) confirming their interest in participation and committing to the principles of the procedure by signing the agreement defined by the procedure (Appendix 1). The countries of NRAs that are currently participating in the procedure are listed on this webpage. Additional NRAs may be invited to participate by WHO if applicants express interest in registering their FPPs in countries whose NRAs are not yet participating in the Procedure.

Any SRA that wishes to participate must:

a) agree that the holder of the SRA marketing authorization can share with the relevant NRAs the assessment and GMP inspection reports for the FPP and validate the QIS (Appendix 4).

b) agree to share additional information with the relevant NRAs, in line with the principles of the procedure, if requested.

Steps for applicants, SRAs and NRAs

The steps to be followed during the procedure are as follows for the different participants:

The interested holder (applicant) of the SRA marketing authorization:

a) agrees with WHO that the procedure will be applied to the specific FPP(s) and that WHO will have access to the data shared with NRAs (Appendix 8)

b) grants the SRA permission to share information concerning the FPP(s) with the relevant NRAs and WHO (Appendix 3b) and requests SRA permission to share the SRA’s assessment and inspection reports with NRAs and WHO (Appendix 3a),

c) submits an expression of interest to NRAs (Appendix 7) followed by an application for registration of the FPP(s), with the same set of technical data, electronically and/or in hard copy, to participating NRAs, in line with the procedure and respecting specific national requirements (Appendices 4, 5, 6).

d) All the signed original documents should be posted or sent by courier to:

World Health Organization

Marie VALENTIN

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

How long does it take?

If the NRA of the country in which the application for registration of the SRA-approved FPP 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 communicate its decision to WHO and applicant (Appendix 9) within a further 30 working days.​

NRA agreement and CRP forms

Appendix 1 in English

Appendix 1 in French

Appendix 1 in Spanish

Manufacturer's forms

Appendix 3a

Appendix 3b

Appendix 4

Appendix 7

Appendix 8

Appendix 9

ePQS –Electronic Prequalification System

Contact us:

prequalreg@who.int

cabacom@who.int