May 1, 2026
Regulatory safety information on medicinal products from national pharmacovigilance centres worldwide and the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP).
Regulatory safety information on medicinal products from national pharmacovigilance centres worldwide and the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP).
ATMPs are dynamic, often patient‑specific, and designed to achieve durable or even curative effects through permanent genetic modification, cellular engraftment, or tissue regeneration.
The European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), has established comprehensive guidance for risk management plans (RMPs) for novel therapy veterinary medicinal products (NT-VMPs).
The National Institute for Health and Care Excellence (NICE) guideline NG28, updated in 2026, provides comprehensive recommendations for healthcare professionals on selecting, reviewing, and modifying glucose-lowering therapies in adults with type 2 diabetes.
Based on the EMA Guideline on Good Pharmacovigilance Practices (GVP) Chapter P.III – Product- or Population-Specific Considerations III
The Egyptian Drug Authority (EDA) has established a structured framework for managing variations to pharmaceutical products in the post-marketing phase. The document titled Administrative & Relevant Documents & Time frame for human pharmaceutical variations (Version 1/2026, Code NP. CAPP.109) serves as a critical guideline for applicants seeking to modify registered medicinal products.
New Zealand's Medsafe provides clear guidelines outlining the responsibilities and processes for ensuring participant safety during clinical investigations of both medicines and medical devices.
Advancing Medication Safety Through Knowledge and Vigilance
