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New guideline to use reliance for emergency use authorization of medicines and other technologies during COVID-19 pandemic

30 Apr 2020

Washington DC, 23 April 2020 (PAHO)—The Pan American Health Organization held a virtual meeting on COVID-19 regulatory update to present and discuss the document “Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)”. More than 110 participants, including delegates from the World Health Organization (WHO) and from National Regulatory Authorities (NRAs) from the Americas, convened in the meeting, which took place on 23 April 2020.

“We are facing a totally unprecedented public health emergency, and NRAs face a big challenge to navigate the complex dynamics of product approvals during the COVID-19 pandemic situation,” said Jarbas Barbosa, Assistant Director of PAHO. “Today we will focus on reliance that is one of the most important tools that NRAs have to speed up the review processes, but at the same time, ensure the quality, safety, and efficacy of medical products.”  

PAHO’s document “Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)” provides guidance to national regulatory authorities and regulatory systems on practical ways to implement reliance strategies for emergency use of medicines and other health technologies during a pandemic. 

“Regulatory systems have a major role to play during pandemics to ensure that the products that are authorized for use in an emergency comply with quality and safety standards”, said Analía Porrás, Chief of the Medicines and Health Technologies Unit at PAHO. “The implementation of these recommendations can contribute to the strengthening of NRAs regulatory capacities and accelerate national approval of specific products needed in the national health systems to address the COVID-19 pandemic,” she added. 

The document, which is based on the WHO Pandemic Influenza Preparedness guidelines, highlights that countries are encouraged to develop plans for regulatory preparedness and response in a pandemic including related to Emergency Use Authorization (EUA) of medicines and health technologies. This will afford an orderly and legal process to expedite the incorporation of these products into health systems. 

When applying the EUA, PAHO recommends that NRAs expedite their reviews in EUA situations and put in place procedures for reliance and recognition. Also, PAHO suggests ensuring that the exact same product approved in trusted/reference authority is what will be sold in the NRA´s market. 

PAHO presented the suggested technical requirements for pharmaceuticals, vaccines, and in vitro diagnostic (IVDs) for EUA, which are:  product category, assurance of sameness; product description; manufacturing information; product labeling; and post-market surveillance. PAHO recommends an approach that uses reliance on the product EUA from the trusted/reference authorities and verification of the supporting documentation in the national official language of the NRA. 

To illustrate the use of reliance, Christine Lefebvre and Daniel Yoon, from Health Canada, presented their regulatory experience on the use of the Interim Order to bring COVID-19 in vitro diagnostic into Canada. Moreover, Irena Prat, from WHO, presented on “Applicability of the WHO Emergency Use Assessment and Listing Procedure (EUAL) for Candidate IVDs for Use in COVID-19 pandemic”. 

PAHO’s extensive response to the pandemic has centered on supporting countries with technical guidelines, training, supplies, and information. In March 2020, PAHO formed a network with focal points from the NRAs, made up of 35 countries from all the Sub-regions of the Americas, in addition to representatives from the Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) and the Organization of Eastern Caribbean States (OECS). PAHO maintains regular communication with the network on regulatory actions implemented at the regional level and in other regions. The virtual meeting was the third meeting held by PAHO to discuss updates on the regulatory response and to address challenges and concerns. This initiative is key to identify areas where immediate support is needed and to better plan the pandemic response.