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March 29, 2024

GHTC welcomes the recent announcement by the World Health Organization (WHO) that it will apply parallel, rather than sequential, processes in developing guidelines recommending the use of novel health products and certifying their safety and efficacy via prequalification (PQ) and/or Emergency Use Listing (EUL). Many of our members and partners have highlighted how the prior procedure, which required guidelines to be in place as a prerequisite to EUL or PQ, was a major bottleneck for innovative products—adding significantly to approval timelines and delaying access to critical new health technologies in low- and middle-income countries.

We believe that this new parallel process, which was first trialed during the pandemic for COVID-19 products, could significantly improve and accelerate access to vital innovative health technologies in countries that rely on WHO recommendations for the use of these products.

We urge WHO to provide additional details on the implementation of this new process and encourage the PQ program to provide a platform for continued feedback and input from key stakeholders, including product developers, national regulators, procurers, and civil society.

We believe that WHO’s PQ program continues to be an essential link in the regulatory ecosystem, and we hope this is just one of several steps WHO will take to reduce bottlenecks and improve the program’s efficiency and impact.