Public bodyThe Netherlandsema.europa.eu
The European Medicines Agency (EMA) is the European Union’s decentralized agency responsible for the scientific evaluation, authorization, and supervision of medicines for human and veterinary use. Headquartered in Amsterdam, it coordinates a network of national competent authorities and expert committees to assess quality, safety, and efficacy, and to manage post‑marketing safety through pharmacovigilance. The EMA’s centralized procedure can grant a single marketing authorization valid across EU/EEA member states.
For the chemical and pharmaceutical value chain, the EMA sets and interprets standards for active pharmaceutical ingredients and excipients, evaluates chemistry, manufacturing and controls (CMC) data, supports GMP/GDP oversight and inspections in cooperation with national authorities, and issues guidance on impurities and quality risks (including nitrosamines). It operates key regulatory platforms such as EudraVigilance for safety reporting and the Clinical Trials Information System (CTIS), and provides scientific advice and pathway designations (e.g., orphan, pediatric, and advanced therapies) that shape development and manufacturing requirements across Europe.
None yet. When a new project in the record names EMA as owner, partner or investor, it shows here.
Positive opinions for multiple veterinary authorisations including Scovella (velagliflozin) under the limited market framework; vaccine variations; JIACRA V adoption and regulatory consultations.
Investigations probe serious movement/cognitive side effects and clusters of allergic reactions tied to specific batches; recalls and monitoring advised for affected immunoglobulin products.
Guidance to help start Bundibugyo virus vaccine trials rapidly while maintaining safety: allows some animal-study waivers for known platforms, recommends early African trials, single-dose preference, and ring trial design.
CHMP recommends talquetamab (TALVEY) with daratumumab ± pomalidomide for adults with relapsed/refractory multiple myeloma after ≥1 prior therapy, supported by MonumenTAL-3 efficacy and survival data.
Approvals include Rasonque for metastatic pancreatic cancer, Foundayo oral GLP‑1 for weight and type 2 diabetes, Yuviwel for achondroplasia, two biosimilars and temozolomide for gliomas.
Oral orforglipron showed 5–11% weight loss at 72 weeks and 1.2–1.9 percentage‑point HbA1c reductions; CHMP opinion now goes to the European Commission for an EU licence.
CHMP backs an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma after prior therapy; phase‑3 data show doubled median survival versus chemotherapy and review took under 150 days.
Live attenuated vaccine cuts clinical signs and viraemia from three weeks post‑vaccination and confers protection for one year; authorised under exceptional circumstances; side effects are uncommon.
