In December 2020 the EMA launched a pilot ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics. The EMA announced in June 2023 that the OPEN initiative will be extended to medicines intended to help combat antimicrobial resistance, innovative medicines with PRIME designation (temporarily not ATMPs) and other products which address a high unmet need. The initiative will also be extended to medicines intended to address public health threats and public health emergencies.
The pilot OPEN initiative was launched during the Covid-19 pandemic to further international collaboration to aid the urgent development of new treatments and vaccines across the globe. Non-EU regulatory authorities and selected international organisations would send OPEN experts to participate in meetings of the Committee for Medicinal Products for Human Use (CHMP) and Emergency Task Force (ETF), subject to confidentiality agreements. These included Health Canada, the Japanese Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Swissmedic, the Australian Therapeutic Goods Administration and the World Health Organisation. All Regulators retained full scientific and regulatory independence. The OPEN experts assessed the regulatory information, presented the overall assessment of their authority and contributed to CHMP and ETF discussions, although they did not contribute to any conclusions and decision making and the CHMP assessment report represented the views of the CHMP only. It was intended that the OPEN experts would increase expertise as well as broadening and strengthening the EMA’s scientific reasoning. It was also intended that such collaboration would increase public trust in EU approvals of vaccines and treatments for Covid-19.
The pilot OPEN initiative was considered to have worked well by the EMA, OPEN regulators and applicants, as the collaboration led to accelerated assessments and fewer labelling differences. The OPEN initiative was extended in June 2023 to innovative medicines, namely those with PRIME designation (temporarily not ATMPs) or those addressing a high unmet need, medicines combatting antimicrobial resistance and medicinal products responding to health threats or public health emergencies. Additionally, the Brazilian Health Regulatory Agency will also now participate in OPEN.
The full OPEN initiative will work in the same way as that described for the pilot OPEN scheme in operation for Covid-19 treatments and vaccines, however, more explicit rules of engagement for OPEN experts provide enhanced clarity on how and when to engage during the EU assessment. OPEN products will be selected early on in the procedure, so that OPEN partners can discuss timing of submissions with the applicant, and will depend upon a minimum of one OPEN partner being interested in collaboration, alignment of dossier content/claimed indication and submission date. EMA will indicate that a product is being assessed under the OPEN framework in the published CHMP agenda and minutes. Once validated by the EMA, OPEN experts may attend CHMP meetings and contribute to discussion, evaluate, review and provide written comments on the EMA assessment report (preliminary report, List of Questions and Updated report, all provided to OPEN experts by the applicant), interact with Rapporteurs if invited and actively share their own assessment reports and List of Questions with the EMA. As for the pilot, OPEN experts will not contribute to CHMP conclusions during the final benefit-risk decision. Currently, the EMA identifies potential medicinal products for inclusion in the OPEN initiative and informs the applicant, however, in time companies will also be able to proactively ask for their medicinal product to be part of OPEN.
The intended benefits of the OPEN initiative include alignment of dossiers to improve regulatory convergence within OPEN partner countries, leading to faster overall global approval and the potential to align the post-approval lifecycle for major changes.
Report; OPEN Pilot: One-year review and recommendations, European Medicines Agency, EMA/6881/2022, 17 March 2022
Presentation (EMA, Irene Rager, Radhouse Cherif); OPEN – International collaboration, Industry Stakeholder Platform on centralised procedure meeting, 27 June 2023.
Questions and Answers on the ‘OPEN’ Framework; Opening our Procedures at EMA to Non-EU authorities, International Affairs, EMA/55338/2023, 3 July 2023