Collaborative procedure between the World Health Organization (WHO) Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines

1. Definitions:

Collaborative procedure (Procedure):

Procedure for collaboration between the World Health Organization (WHO) Prequalification Team (WHO/PQT) and interested national regulatory authorities (NRAs) in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines.

Participating authorities or participating NRAs:

NRAs that voluntarily agree to implement this collaborative procedure and accept the task of processing applications for registration of WHO-prequalified pharmaceutical products and vaccines in accordance with the terms of the Procedure. A list of participating authorities is posted on the WHO/PQT website (for pharmaceutical products at http://www.who.int/prequal/, and for vaccines at http://www.who.int/immunization_standards/vaccine_quality/expedited_review/en/).

Pharmaceutical product:

Any substance or combination of substances marketed or manufactured to be marketed for treating or preventing disease in human beings, or with a view to making a medical diagnosis in human beings, or to restoring, correcting or modifying physiological functions in human beings.

Vaccine:

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, one of its surface proteins or genetically-engineered material. The agent stimulates the body’s immune system to recognize the agent as foreign, destroy it and “remember” it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.

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Table of Contents

1. Definitions

2. Background information

3. Principles of collaboration

4. Steps in the collaboration for national registration of a pharmaceutical product or a vaccine

5. Collaboration mechanisms for post-prequalification and/or post-registration variations

6. Withdrawals, suspensions or delistings of prequalified pharmaceutical products or vaccines and national deregistrations

References

Appendix 1: National regulatory authority participation agreement and undertaking for national regulatory authority focal point(s)

Appendix 2: Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the Procedure

Appendix 3: Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of Procedure outcomes