‘Faster Global Drug Approval’ Possible Under EMA’s Extended Reliance Framework
Drugs for Alzheimer’s disease, amyotrophic lateral sclerosis and other high unmet medical needs are among the new products that will now be eligible for assessment under the OPEN framework, the European Medicines Agency’s initiative for collaboratively assessing marketing applications with non-EU regulators.
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The first products to be selected for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities are from Pfizer/AbbVie and Moderna.
The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Genmab/AbbVie’s Tepkinly, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.