EU MDCG Guidance Library for Medical Devices and IVD Regulations
The European Commission maintains a comprehensive online collection of Medical Device Coordination Group (MDCG) endorsed guidance documents and related resources.
Precautionary Recall Alert: Mercaptopurine 50mg Tablets from Aspen Pharma Due to Microbial Contamination
Aspen Pharma Trading Limited has initiated a recall of a specific batch of Mercaptopurine 50mg tablets distributed under brand name(s).
May 2025 MHRA Safety Updates: Key Guidance for Medicine and Medical Device Users
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its May 2025 Safety Roundup, providing updated safety guidelines and
Swissmedic Introduces Preliminary Decision Clarification Meetings for Human Medicinal Products
Swissmedic has announced an important update for stakeholders involved in authorisation procedures for human medicinal products. Starting soon, a new
Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims to streamline the identification
Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical Device Regulators Forum (IMDRF),
Urgent Recall of Batch-Specific Omeprazole Oral Solution Due to Quality Concerns
On October 2, 2025, Glenmark Pharmaceuticals Europe Ltd announced a precautionary recall of a specific batch of its Omeprazole 20
FDA Introduces Daily Updates on Adverse Event Reporting for Drug Safety Insights
The U.S. Food and Drug Administration (FDA) has announced a major step forward in public health transparency by initiating daily
Zaditen Eye Drops Recall Announced Over Microbial Contamination Risks
In a recent update concerning pharmaceutical safety, Thea Pharmaceuticals Limited (trading as Laboratoires Théa) initiated a Class 2 Medicines Recall
Critical Update: Field Safety Notifications Released for Medical Devices (22–26 September 2025)
In a recent regulatory update crucial for healthcare professionals, the Medicines and Healthcare products Regulatory Agency (MHRA) published Field Safety