Emergency Use Listing Procedure
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
The procedure is a key tool for companies wishing to submit their products for use during health emergencies.
Eligibility of candidate products
The EUL concerns three product streams (vaccines, therapeutics and in vitro diagnostics), each of which has specific requirements for products to be eligible for evaluation under the EUL procedure.
The following criteria must be met:
- The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children);
- Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);
- The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs; and
- The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.
Evaluation will determine whether, in light of available WHO/international standards, the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety and effectiveness are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.
Application for an EUL
The submission for EUL of a vaccine should follow the ICH common technical document (CTD) format.
For information on the formatting and requirements of an eCTD dossier please follow this link
The vaccine manufacturer must apply to WHO with the following information:
- manufacturing quality data
- non-clinical data and clinical data
- a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
- labelling details.
A decision to issue an emergency use listing for a vaccine is accompanied by a series of recommendations or conditions that must be addressed by the EUL holder within the timelines discussed and agreed upon the at the time of the EUL recommendation. These conditions are referred to as Post-EUL Commitments and are part of the EUL process.
In addition, the applicant must notify WHO of any changes to the vaccine’s manufacturing process, including changes to specifications, analytical methods or labelling, new manufacturing facilities or scale up of commercial production, as per the Post-EUL Submissions procedure. Post- EUL changes will be evaluated according to the type of change introduced. The outcome may or may not be consistent with the approval of the change(s) by the NRA of record.
All submitted information will be assessed to determine whether the vaccine’s benefit‒risk ratio remains positive.
WHO reserves the right to issue an information notice for procurement agencies and relevant programmes, if at any time, WHO deems that the EUL holder has not responded to a post-listing quality and/or safety issue in a timely and/or scientifically-sound manner. If quality and/or safety issues are identified post listing, WHO may seek advice from the Technical Advisory Group for emergency use listing (TAG EUL). WHO reserves the right to restrict or revoke the emergency use listing of the vaccine product in instances where a quality/safety issue has not been or cannot be resolved to WHO’s satisfaction.
See in particular:
- page 10 for information about agreements with national regulatory authorities for information sharing
- pages 16 ‒17 summary of activities carried out during the three phases of an EUL
- page 18 for a flowchart of the EUL process
- Annex 2 on pre-submission meetings
- Annex 5 for essential data requirements for EUL for vaccines.