Europe – 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…