The current pandemic makes it essential to develop and roll out new options and medicinal products for the treatment of COVID-19 as quickly as possible. As part of this process, Swissmedic took part in a COVID-19 workshop organised by ICMRA to discuss how data from clinical practice could most beneficially be channelled into clinical trials of potential medicinal products or vaccines.
International medicinal product regulatory authorities hold online workshops to improve treatment options for coronavirus disease 2019 (COVID-19)
Experts discuss findings from data in workshop organised by the International Coalition of Medicines Regulatory Authorities (ICMRA)
Representatives of regulatory authorities met online in early April to discuss information on ongoing and planned COVID-19 observational studies aimed at characterising the disease and generating further findings on possible COVID-19 vaccines and therapeutic agents. They shared practical information on research issues, protocols and procedures with the aim of ensuring the reliability of results for the fulfilment of official requirements.
Participants from more than 25 countries representing 28 medicinal product regulatory authorities worldwide were joined by experts from the World Health Organization (WHO) and the European Commission. The workshop acknowledged the significance of observational studies based on real-world data as a contribution to the development, authorisation and monitoring of medicinal products and vaccines and to overcoming knowledge gaps that clinical trials are unable to plug. Shared use of protocols and results was identified as one critical aspect of the global approach, along with the inclusion of established platforms for this purpose.
The workshop on data from COVID-19 observational studies was part of a series of virtual workshops held in March and April 2020. Previous workshops addressed the development of vaccines against the new SARS-CoV-2 coronavirus, potential therapeutic agents, clinical trials and compassionate use programmes.
The workshops reaffirm the regulatory authorities’ obligation to work together globally and to improve global-level information-sharing on research and development work on treatments and vaccines for COVID-19.
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global, multilateral initiative involving the heads of medicinal product regulatory authorities. ICMRA promotes inter-authority cooperation on current and emerging human medicine regulatory challenges with the aim of strengthening the quality, safety and efficacy of medicinal products worldwide. Its priorities also extend to coordinated responses to crisis situations in the interests of protecting public health.