Tag: Clinical Trials

Pharma – Asia, S America, MENA, ROW Regulatory News – Oct 2025

Biopharma

ARGENTINA ANMAT Unveils QR Code System for Drug Leaflet Updates On October 16, 2025, ANMAT presented a new digital system to Argentina’s pharmaceutical chambers for generating QR codes on drug...

ANMAT, Clinical Trials, Digital Health Transformation, Drug Safety, e-CTD, Global Regulatory Harmonization, Pharma Regulatory News, QR Code Drug Labeling, SFDA AI, TGA

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

Biopharma

USA FDA Approves a New Non-Opioid Therapy for Acute Pain The U.S. Food and Drug Administration has officially approved for Journavx (suzetrigine) 50 mg oral tablets, marking the introduction...

BioPharma, BioTech, Clinical Trials, Drug Approval, EMA, FDA, Healthcare Pharma Regulations, Pharma News, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – June 2024

Biopharma

EUROPE FDA Authorizes First Point-of-Care Hepatitis C RNA Test The FDA has granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System—the first test enabling...

Biotech Updates, Clinical Trials, Drug Safety, EMA, FDA, Global Health, Healthcare Regulations, Medical Devices, Pharma News, Regulatory News

Global Regulatory Intelligence

Standards

The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes keep evolving and vary across markets. Establishing an effective regulatory...

Clinical Trials, Compliance Procedures, Health Authority, Manufacturing Requirements, Regulatory Intelligence