OPEN framework extended to a wider range of medicines
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 (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.
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 (ATMPs);
- medicines with the potential to address RSV infections or newly diagnosed myelodysplastic syndromes and other hereditary diseases; and
- medicines responding to health threats or public health emergencies.
The first product currently 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 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 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.
Further information is available in the updated Q&A document .
More on OPEN
OPEN was launched as a pilot in December 2020. All COVID-19 vaccines and therapeutics evaluated since the launch of the pilot were assessed under the OPEN framework. Participating non-EU experts attended and contributed to CHMP and EMA’s Emergency Task Force (ETF) evaluations. The extension of the OPEN framework is based on the positive findings and recommendations highlighted in the report on the OPEN pilot.
EMA 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.