Recentes

• The FDA’s updated compliance program manual
• The FDA’s Quality Management System Regulation (QMSR) is now LIVE and fully effective
• ICH M11 guideline, clinical study protocol template and technical specifications – Scientific guideline
• Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)
• COMMISSION IMPLEMENTING DECISION (EU) 2026/193 of 28 January 2026
• AUDITORIA A DOSSIERS DE AIM: “Formação clara, prática e com partilha de experiências”
• HERBAL FOOD SUPPLEMENTS .Guide for healthcare professionals
• M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality