This is a regularly updated searchable list of products that have been filed with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) under the EU’s centralized authorization procedure. The information is based on the EMA’s monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet.
New EU Filings
Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.