WHO Drafts New Prequalification Timeline, KPIs

Posted 07 August 2017 By Zachary Brennan

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As part of efforts to better monitor and improve the performance of its prequalification program, the World Health Organization (WHO) has proposed a new algorithm to calculate the prequalification timeline and drafted new key performance indicators (KPIs) to track. 

Background

Each year, billions of dollars are spent on medicines by international procurement agencies for distribution in resource-limited countries. WHO’s prequalification of medicines is a service to assess the quality, safety and efficacy of medicinal products and is intended to give these agencies the choice of a range of medicines for bulk purchase.

Originally in 2001, the focus of the program was on medicines for treating HIV/AIDS, tuberculosis and malaria. But in 2006, the focus was extended to cover medicines and products for reproductive health and in 2008, to cover prequalification of zinc, for managing acute diarrhea in children. By the end of 2012, the WHO List of Prequalified Medicinal Products contained 316 medicines for priority diseases.

New Algorithm and KPIs

The new algorithm to harmonize prequalification timelines for IVDs, medicines and vaccines is "based on the assumption that the dossier review is the principal component of the assessment," WHO says, noting that it may also "affect prequalification timelines." The algorithm’s implementation is also dependent on a new IT system for WHO prequalification that is expected to go live in October 2018.

The new algorithm is based on two rules, WHO says:

  • "Rule 1 – From acceptance for assessment to dossier final decision, the split between WHO time and manufacturer time applies only to the dossier review component.
  • Rule 2 – If at the time of dossier final decision the inspection or, when applicable, the laboratory component, is still being performed, then after this point the split between WHO time and manufacturer time is counted only with respect to the longest-running component, i.e. the component that determines conclusion of the prequalification process, and therefore of the prequalification timeline."

As far as the new KPIs, WHO says the aim is to measure the program's responsiveness, that is "the time after which the manufacturer can expect first complete feedback, covering each assessment component."

The KPIs and algorithm are now available for review and comment and may be modified based on the comments or any implementation issues. Comments can be submitted by email to prequal@who.int until 26 August 2017.

WHO

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Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Regulatory strategy, Regulatory intelligence, News, US, Europe, Asia, WHO

Tags: WHO prequalification

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