International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development, authorisation and monitoring of safe, effective and high-quality vaccines and medicines against COVID-19. This was highlighted in a series of regulatory workshops, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) in the first weeks of 2021, which focused on three areas: responding to emerging COVID-19 virus variants, addressing knowledge gaps regarding COVID-19 vaccines and treatments in pregnant and breastfeeding women, and strengthening collaboration on safety monitoring of vaccines.
Timely response to emerging COVID-19 virus variants
In light of the possible spread of new SARS-CoV-2 variants globally and the need to consider rapid updates of current vaccines, experts from ICMRA member organisations discussed current surveillance activities to monitor the spread of any new virus variants and the data that would be required to swiftly approve updated versions of available vaccines against the emerging strains. A meeting report provides an overview of the possible minimal requirements for regulatory approval of new vaccines, or updated versions of already-approved vaccines. EMA and US Food and Drug Administration (FDA) co-chaired the workshop.
Addressing knowledge gaps regarding COVID-19 vaccines and treatments in pregnancy and lactation
The development and authorisation of COVID-19 vaccines and therapies that are safe to use in pregnant and breastfeeding women are of particular concern. Meeting participants acknowledged the knowledge gaps regarding medicine efficacy and safety in pregnant and breastfeeding women. They stressed the need for international collaboration and harmonisation to develop a new global approach and obtain systematic data on these population groups. The workshop was co-chaired by EMA, US FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The findings of the workshop are presented in a meeting report.
Promoting international collaboration on COVID-19 vaccine safety monitoring
International collaboration on safety monitoring, signal detection and rapid exchange of information on the safety of COVID-19 vaccines are crucial to foster regulatory alignment and can play a role in supporting vaccine confidence. The participants of this workshop stressed that joint work among regulators was needed in order to learn from each other, take appropriate mitigating measures (where needed) and communicate in a consistent way across regions to build and maintain public trust in vaccines. A meeting report summarises the outcomes of the workshop. EMA and the Therapeutic Goods Administration (TGA) of the Australian Government Department of Heath co-chaired the workshop.
ICMRA is organising international regulatory workshops on COVID-19-related topics to allow for in-depth discussions between medicine regulators and to agree on common approaches. In addition to delegates representing 28 medicines regulatory authorities globally, participants include experts from the World Health Organization and the European Commission.
ICMRA will build on the knowledge and experience gained from these workshops on COVID-19 medicine regulation and will continue dialogue with global regulators through various forums.