Mapping of Emergency Use Pathways
Please find attached a recent CIRS document giving a very good overview about regulatory emergency use pathways and regulatory flexibilities during COVID-19 pandemic.
Alignment of regulatory approaches and regulatory flexibility during COVID-19
In a high-level meeting on COVID-19 policies, organised by European Medicines Agency (EMA) on 30 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA, see more at http://www.icmra.info/drupal/en/home ), WHO and international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease.
The participants focused on regulatory considerations and challenges related to the development of medicines and vaccines for the prevention and treatment of COVID-19. They raised concerns about multiple small, rather than large clinical trials and stressed the need for the development of priority criteria for planned trials. In addition, they called for the inclusion of vulnerable or neglected populations, such as pregnant women, children and elderly people in COVID-19 studies.
The regulators reiterated that it is crucial to align on common study protocols to ensure that the results meet regulatory requirements and allow the evidence to be used to support the approval of medicines or vaccines.
Regulators also discussed the development, evaluation and use of diagnostic tests in the fight against coronavirus disease. They shared insights into diagnostic accuracy and reliability of serological tests for COVID-19 used in different countries. Meeting participants agreed to make, in collaboration with WHO, an ICMRA inventory of approved tests for COVID-19 to ensure a comparability of the results and to align regulatory approaches.
All participants committed to continue the exchange of information on high-level regulatory flexibilities to enhance the efficiency and effectiveness of regulatory decision-making during the current pandemic.
EMA and FDA are taking it in turns to chair these meetings.
For information on the 30 April meeting, see
Key criteria for the ethical acceptability of COVID-19 human challenge studies
WHO has published criteria for ethical acceptability of human challenge studies but does not advocate a position on this issue. The safety of participants is a key priority in challenge study design – finding this balance is critical through risk minimization; choosing low risk participants, and rigorous consent. The document outlines 8 key criteria – from the scientific justification, risk/benefit assessment, engagement through to site and participant selection, expert review and consent. The document is focused on the need for international cooperation, and focuses on the need for co-ordination, public engagement, careful site selection, and independent review.
The document is available at: https://www.who.int/ethics/publications/key-criteria-ethical-acceptability-of-covid-19-human-challenge/en/
Candidate vaccines for SARS-CoV-2
A landscape analysis of candidate SARS-CoV-2 vaccines is regularly published by WHO.
The 05 May 2020 version of the landscape analysis is available at: https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines
Candidate therapeutics for COVID-19
A living research mapping of candidate COVID-19 therapeutics, displaying studies per country, showing study design, disease severity in study participants, and type of treatment being studied, as well as network maps of these studies, has been made available at: https://www.covid-nma.com/dataviz/
Living synthesis of Covid-19 study results
A list of treatment comparisons, a summary of the evidence for that comparison, and a detailed description of primary studies, including a risk of bias assessment is at: https://covid-nma.com/living_data/index.php