by Admin | Mar 22, 2026 | Explainers
EMA’s January 2026 PRAC statistics show 140 PSUR recommendations, along with reviews of risk management plans and study protocols and results. That is a useful snapshot of the scale of routine pharmacovigilance work happening in the background. For readers new to the...
by Admin | Mar 22, 2026 | Inspections & Compliance
EMA says the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) was established under Regulation 2022/123 and is responsible for helping ensure a robust response to issues affecting the quality, safety, efficacy, and supply of medicinal...
by Admin | Mar 22, 2026 | AI & Digital PV
EMA has scheduled a CTIS sponsor end-user training programme for 8–11 June 2026. The event listing places the training firmly within the live operational environment for European clinical trials. That matters because CTIS competence is increasingly relevant for...
by Admin | Mar 22, 2026 | AI & Digital PV
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA notes that the FAQs should not be treated as a binding commitment, but the document still shows where users...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing authorisation applications. While not a pharmacovigilance page, this kind of pathway guidance matters because...
