Tag: TGA

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

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

Medical Device

USA Final Guidance: Computer Software Assurance FDA released its long-awaited final guidance on Computer Software Assurance (CSA), replacing Section 6 of the 2002 software validation guidance....

CSA software validation, eSTAR submissions, EU MDR, FDA guidance, Global Regulatory News, Health Canada, Medical Device Compliance, medical device cybersecurity, Medical Device Regulations, MHRA clinical investigations, TGA

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

Biopharma

ALGERIA Suspension and Withdrawal of HUP.P.PHARMA Products The National Agency for Pharmaceutical Products has announced the immediate suspension and withdrawal of all pharmaceutical products...

drug recalls, EDA, global pharma, GMP standards, NMPA, Pharma Regulatory News, pharmaceutical updates, Regulatory Compliance, TGA