WHO to add Prequalification Fees to Keep Program Sustainable

Prequalification is a service provided by WHO to assess the quality, safety and efficacy of in vitro diagnostics, medicines, active pharmaceutical ingredients and vaccines for priority diseases and which are intended for UN and international procurement to developing countries.

WHO have currently prequalified 516 medicines, 180 vaccines and 64 in-vitro diagnostic tests, with an average rate of prequalifying 80 medicinal products each year. Once evaluated, if the products are deemed compliant, they are listed as eligible for procurement on a public website.

The fees, set to launch in January 2017 for vaccines and medicines, and early 2018 for diagnostics, will cover manufacturing site inspections, product assessments, training and any mentoring needed by companies to bring products up to standard.

What are the fees?

Medicines

Single Registration Fee Annual Fee Per Product
New application full assessment New application abridged assessment Annual fee full assessment Annual fee abridged assessment Major variation Minor variation or variation in an abridged assessment product
FPP (Rx) $25,000 $6,000 $20,000 $5,000 $3,000
API $20,000 $8,000 $3,000

There is the possibility for the fees to be negotiated for smaller companies.

Read the full article at RAPS here.

Tagged with

Published on 3. October 2016 in News EU