Regulatory round-up: 8 December 2025

Regulators across Europe and the UK have issued a steady stream of medicines decisions over the past week, ranging from new product authorizations to targeted product recalls. Several updates focus on manufacturing or packaging issues, reflecting ongoing scrutiny of supply-chain quality.

The European Commission has cleared multiple new biosimilars following positive assessments from the European Medicines Agency (EMA), adding fresh competition in osteoporosis and oncology-related care. These decisions continue the EU’s wider push to broaden access to high-value biologics.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has published several safety notices, including batch recalls for common cardiovascular and neurological medicines. The agency also issued a packaging-related defect notification, reinforcing the heightened emphasis on clear patient information and safe dispensing.