EMA extends OPEN framework to a wider range of medicines

Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines, such as those with the potential to address antimicrobial resistance (AMR), respiratory syncytial virus (RSV) 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 (WHO) to conduct near-concurrent reviews of certain new medicines and exchange their views and reports on the product assessments. This can help accelerate and align regulatory decisions in several regions in the world, leading to fewer questions for industry and more alignment on the product labelling, while maintaining regulators’ independence in their decision making.