Posted by Michael Wonder on 20 Jul 2023
OPEN framework extended to a wider range of medicines
20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines, such as medicines with the potential to address antimicrobial resistance, respiratory syncytial virus infections or newly diagnosed myelodysplastic syndromes (and other hereditary diseases).
OPEN was established by EMA in December 2020 as a framework to increase international collaboration and share scientific expertise on the evaluation of COVID-19 vaccines and therapeutics, initially as a pilot. It allows regulators from Australia, Brazil, Canada, Japan, Switzerland and the World Health Organization to conduct near-concurrent reviews of certain new medicines and exchange their views and reports on the product assessments.
