Safety Observer 195

SFDA updates GVPs

The Saudi FDA has published a revised version of its Guideline on Good Pharmacovigilance Practices (GVPs), which includes some significant changes to the ICSR reporting rules, amongst others.

Pholcodine

The EMA Safety Committee has concluded that pholcodine-containing medicines should be withdrawn from the EU market due to the risk of anaphylactic reactions to neuromuscular blocking agents (NMBAs).

PV Inspections

Both the Australian Therapeutic Goods Administration (TGA) and the Saudi FDA have published Metrics Reports presenting information about the Pharmacovigilance Inspections performed.