DEADLINE EXTENDED TO 15 DECEMBER 2018
WHO developed the EUAL mechanism in response to the 2014 – 2016 Ebola outbreak. The EUAL is a risk-based procedure for assessing and listing candidate in vitro diagnostics (IVDs), therapeutics and vaccines for use during public health emergencies. The current procedure consists of three key components:
1. review of the documentation relating to the manufacture of the product, including compliance with WHO manufacturing quality norms and standards;
2. review of documentation relating to safety and efficacy/ performance, especially with respect to use in the area of the public health emergency; and,
3. where applicable for diagnostics, an independent laboratory evaluation, coordinated by WHO, of the product’s performance and operational characteristics.
The WHO Informal Consultation on options to improve regulatory preparedness to address public health emergencies (Geneva, May 2017) concluded that some aspects of the existing WHO EUAL procedure need to be reconsidered and revised. The consensus was to reframe the process as the Emergency Use Listing (EUL) procedure.
The goal of the new procedure is to define the steps that WHO will follow to establish eligibility of products, the minimum information required and the process to conduct the assessment to make a product available under a limited time listing status, while further data is being gathered and evaluated.
A drafting group has developed this version that will be circulated to stakeholders for comments.
Please submit your comments to email@example.com not later than 30 November 2018.