Regulatory round-up: 6 October

Regulators focused on pragmatic safety messaging this week, with aligned statements that paracetamol remains appropriate in pregnancy when used as directed. Australia’s Therapeutic Goods Administration (TGA) also issued a neonatal safety alert for topical anesthetics.

Operational updates continued: the UK Medicines and Healthcare products Regulatory Agency (MHRA) began its clinical-trials Route B pilot, the South African Health Products Regulatory Authority (SAHPRA) launched an e-CTA pilot, and Swissmedic published several approvals in its monthly journal.

Compliance and enforcement remained active in Australia, while the European Medicines Agency (EMA) and its Pharmacovigilance Risk Assessment Committee (PRAC) met in Amsterdam with a packed agenda. Formal highlights are expected soon.