EMA Extends OPEN Framework to More Medicines

On July 20, 2023, the European Medicines Agency (EMA) announced their expansion of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines. These medicines can potentially address respiratory syncytial virus (RSV) infections, antimicrobial resistance (AMR), or newly diagnosed myelodysplastic syndromes (and other hereditary diseases). The new extended scope includes marketing authorization applications for medicines targeting AMR, medicines through EMA’s PRIority MEdicines scheme (not including advanced therapy medicinal products), medicines for RSV infections or newly diagnosed myelodysplastic syndromes and other hereditary diseases, and medicines responding to health threats or public health emergencies.

The first product under OPEN assessment is an messenger RNA (mRNA) vaccine against RSV, which is being assessed alongside Swissmedic. To be eligible for OPEN assessment, medicines require EMA’s human medicines committee (CHMP) and at least one OPEN partner to agree to conduct parallel assessments. Discussions will continue with OPEN partners to select other products for the OPEN framework, and the agency will continue engagement with stakeholders as more experience is gained.

OPEN was created by EMA in December of 2020 initially as a pilot, meant to provide a framework for international collaboration on the evaluation of COVID-19 vaccines and therapeutics. It is used by regulators from Australia, Brazil, Canada, Japan, Switzerland, and the World Health Organization (WHO) to conduct near-concurrent reviews of new medicines and exchange views and reports on product assessments. This collaboration both accelerates and aligns regulatory decisions, leading to more clarity in the industry and more unity on product labeling while keeping regulator’s decision-making independence. “The collaboration with WHO means that OPEN can accelerate regulatory decisions and availability of medicines in low- and middle-income countries,” the agency states in a press release.

The extension of the OPEN framework is based on the positive findings and recommendations, which can be found in a report on the OPEN pilot. EMA wrote that it “has bilateral agreements with all regulatory authorities involved in OPEN. Standard EMA requirements for EU experts participating in the assessment of medicines (e.g., confidentiality and absence of conflicts of interest) also apply to OPEN experts.” Medicines assessed under OPEN will be labeled in publicly available CHMP agendas and minutes, and on EMA’s website.

Source: EMA