‘Faster Global Drug Approval’ Possible Under EMA’s Extended Reliance Framework

The OPEN framework that the European Medicines Agency started running in 2020 to allow international regulators to participate in its evaluation of EU marketing applications for COVID-19 vaccines and therapeutics has been extended to cover products in other therapeutic areas, including those targeting antimicrobial resistance (AMR).

Medicines that address a high unmet medical need, including some of those designated under the EMA’s PRIME scheme, will also be eligible for assessment under the OPEN framework, as will...