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State Medicines Control Agency (SMCA) published a notice regarding medicinal products that may be subject to the “sunset clause.” The agency compiled a list of…

U.S. Food and Drug Administration (FDA) issued a draft guidance for sponsors seeking approval of human gene therapy products that involve genome editing technologies. Once…

Federal Institute for Drugs and Medical Devices presents updates on the development of the Iris system in relation to the implementation of ICD-11 (International Classification…

Drug Control Authority (DCA) approved updated policies concerning products containing animal-derived materials through Circular NPRA.600-1/9/12 (31). This update introduces a risk-based approach for scientific justification…

Introduction European Medicines Agency (EMA) published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26…

Introduction The Health Sciences Authority (HSA) has introduced regulatory updates related to therapeutic product registration. These updates include the formal adoption of the electronic Common…

Introduction The Estonia State Agency of Medicines has introduced a national accelerated assessment procedure and joined the FAST-EU initiative to support more efficient conduct of…

Introduction The European Medicines Agency (EMA) has introduced three new features under its PRIME scheme to enhance the development of medicines targeting unmet medical needs.…

Introduction The Medicines and Medical Devices Agency of the Republic of Moldova announced that the government has approved new Good Manufacturing Practice (GMP) rules aimed…

Introduction The Spanish Agency for Medicines and Health Products (AEMPS) has published the annual report of the Spanish Pharmacovigilance System for Medicines for Human Use…

Introduction The U.S. Food and Drug Administration announced on March 11, 2026, the launch of a new unified platform for analyzing adverse event reports. The…

Introduction Clinical trials are the cornerstone of evidence-based medicine, providing essential data on safety, efficacy, and quality of medicines. During public health emergencies (PHEs), the…

Belgium has introduced a new digital reporting platform designed to strengthen safety monitoring in blood transfusion systems. The initiative was announced by the Federal Agency…

The U.S. Food and Drug Administration (FDA) has announced the availability of the guidance titled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and…

The U.S. Food and Drug Administration (FDA) has announced the availability of the final guidance titled “M14 General Principles on Planning, Designing, Analyzing, and Reporting…