RAPS

Euro Roundup: EMA releases strategy for implementing ICH guideline on post-approval safety data

The European Medicines Agency (EMA) has published a strategy for implementing international guidelines on managing post-approval safety data. EMA’s strategy applies to the first revision of the ...
GEN

Continuous Manufacturing and AI Advances Prompt Revised EMA Strategy

European authorities have issued an updated strategy for the regulation of drugs in the EU, citing recent advances in manufacturing technology and methods as drivers for the revision. The updated ...
TMCnet

InflaRx Assessing Feasibility of Broadened Strategy for ANCA-Associated Vasculitis in Europe Following EMA Recommendation on Tavneos

InflaRx intends to engage with EMA regarding both vilobelimab and izicopan to evaluate the regulatory path to approval in ANCA-associated vasculitis (AAV) The Company is assessing the most efficient ...
FierceBiotech

The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

In 2026, the global regulatory framework for cell-based therapies continues to evolve, placing increased emphasis on robust CMC control strategies, comparability planning, and lifecycle management. As ...