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October 31, 2023

GHTC contributed the below input to a World Health Organization (WHO) Science Division consultation around a new framework to align and expedite the two interrelated processes of prequalifying novel products and issuing technical guidelines to recommend use.

GHTC feedback for new World Health Organization Prequalification evaluation procedure for novel products

The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. 

GHTC has been focused on possible improvements to the WHO prequalification program (PQ) for several years and published a report last year together with Duke University that highlighted some of the perceived pain points and areas of opportunity.

GHTC welcomes the updated guidance that WHO will apply parallel, rather than sequential processes, in its guidelines development and prequalification and/or emergency use listing (EUL) to all new and novel health products that it needs to assess. Many of our members and partners have outlined the reliance on guidelines being the first step in the process as a major bottleneck for innovative products and highlighted how it adds significantly to timelines, delaying access to critical new health technologies in low- and middle-income countries (LMICs).

The following outlines questions GHTC hopes will be answered as part of the consultation process and general feedback on what should be considered as part of this consultation, or where there could be opportunity for additional clarification:

Regulatory agencies in LMICs

 Questions we hope this consultation will address: 

  • How will this new procedure intersect with other shifts in the global regulatory ecosystem? How will PQ look beyond the traditional high-income country stringent regulators and start to integrate emerging regulatory authorities with higher maturity levels into this new PQ process?
  • Will WHO work with global procurers to help assess how they can diversify their quality assessment portfolio?
  • Beyond PQ review of dossiers to inform global procurement, and amid national and regional regulatory strengthening efforts, how will PQ reposition its role in assessing products manufactured in one geography for use in other markets (e.g. African made products which might be procured at a national or regional level in Asia)? 

GHTC contributions:

  • Strengthen other regulatory agencies in LMICs: GHTC continues to hear from partners that they are concerned about additional regulatory barriers coming into play as new bodies, such as the African Medicines Agency (AMA) start to operationalize, and hopes WHO can play an essential role in harmonization (e.g. concerns of a product going sequentially through review by a stringent regulatory authority, PQ, AMA and then a lower maturity regulatory body before a product can be introduced). As WHO PQ develops its new framework for novel products, consideration needs to be given to other regulatory authorities, especially in LMICs, and how their product review can help promote local manufacturing. There could be some countries and regional blocks where WHO Listed Authority (WLA) Level could bypass PQ or significantly expedite PQ approval using maturity levels as markers of expertise. Promoting harmonization and operationalizing of national regulatory efforts (i.e. through AMA) would limit the remit and need for a completely centralized PQ gateway and free up bandwidth within WHO’s PQ team to provide more regulatory technical assistance to national regulatory authorities.
  • Reviewing protocols between global procurers, regulators, and PQ: Across consultations we have done with product developers, national regulators and private sector organizations, there is a lack of consensus on how PQ should interact with global procurers. Some stakeholders are calling on global procurers to diversify the mechanisms to review and approve products. PQ could be one of a menu of mechanisms procurers could leverage for new health products, reducing bottlenecks. On the other hand, many stakeholders see PQ as a critical step before global procurement and would like WHO to update its protocols when working with other regulatory agencies to speed up approvals without sacrificing safety, efficacy, or reviews for programmatic suitability.

Limiting the scope

Questions we hope this consultation will address: 

  • How will the WHO PQ team handle prioritization for their pipeline?
  • How can WHO ensure that it reviews based on global needs, and that when products see smaller changes or updates, WHO is not restarting the whole review process (e.g. not going through an entirely new dossier review when the casing of a diagnostic is changed by the manufacturer)?
  • Might there be any types of products that will not require PQ or that can go through an expedited review after being approved through another WLA 3+ body?

GHTC contributions:

  • Update protocols for triaging generic versus innovative product dossiers: To ensure that PQ can focus and prioritize products with the greatest need and to fill health product gaps, PQ should work with WLA 3+ regulators to develop a category of health products which may not need to go through a full PQ assessment (e.g. generics where bioequivalents and CNC have been demonstrated). Having a more formalized abridged process for generics would enable PQ to better leverage its technical expertise and limited bandwidth to focus on reviewing novel or innovative product dossiers.

Living policy guidelines 

Questions we hope this consultation will address: 

  • How will WHO work internally between the various divisions to ensure clarity for outside stakeholders on the interaction between PQ and policy teams for guidelines?
  • How can WHO ensure that even with the new parallel process, there are no artificial bottlenecks for updating or making changes to guidelines?

GHTC contributions:

  • Further develop protocols for living guidelines: To increase uptake of innovative products, support and advise on the expansion of interim or “living” guidelines, similar to those issued recently for COVID-19 therapeutics and treatments for drug-resistant tuberculosis, for other innovator or novel products to expedite opportunities to address real-time needs.