The European Medicines Agency (EMA) has expanded the scope of the OPEN initiative from Covid-19 vaccines and treatments to a wider range of medicines. The expansion includes medicines 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 the 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 Organisation (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.
The collaboration with WHO means that OPEN can also accelerate regulatory decisions and availability of medicines in low- and middle-income countries.
Following the success of the pilot, the Agency’s Management Board endorsed the expansion of the initiative in March 2022.
The new extended scope of OPEN includes marketing authorisation applications for:
- Medicines targeting AMR;
- Medicines supported through EMA’s PRIority MEdicines (PRIME) scheme, but currently not including advanced therapy medicinal products;
- Medicines with the potential to address AMR, RSV infections or newly diagnosed myelodysplastic syndromes and other hereditary diseases; and
- Medicines responding to health threats or public health emergencies.
The first product being assessed under the new OPEN framework is an mRNA vaccine against RSV, together with Swissmedic. Discussions are ongoing with OPEN partners on the selection of other products to be included in the OPEN framework.
Medicines eligible for assessment under OPEN require the EMA’s human medicines committee (CHMP) and at least one OPEN partner to agree to conduct parallel assessments.
The dossier content/claimed indication and timing of submissions to both the EMA and the OPEN partner(s) should also be aligned. The Agency will engage regularly with stakeholders as more experience is gained.
Medicines assessed under OPEN will be “clearly labelled” in publicly available CHMP agendas and minutes and on EMA’s website, outlined the Agency.