Author:

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 – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

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 – Sept 2025

Biopharma

AUSTRALIA TGA Updates Permissible Ingredients for Listed Medicines Australia’s Therapeutic Goods Administration (TGA) has released Determination No. 3 of 2025, effective 19 September. This update...

ANVISA, drug recall, Drug safety alerts, Global pharmaceutical compliance, NAFDAC alert, NMPA, Pharma Regulatory News, pharmaceutical campaign, PMDA, Regulatory Intelligence, SAHPRA, TGA updates

Medical Devices – Europe, Asia and ROW Regulatory News – Aug 2025

Medical Device

AUSTRALIA TGA focuses on the compliance of AI and software-based medical devices The Therapeutic Goods Administration (TGA) is increasing its regulatory focus on software-based medical devices...

AI in medical devices, Asia medical devices, e-labeling, Europe Medical Devices, Fimea AI Act, GMP for medical devices, Health Canada guidance, Latvia e-instructions, Medical Device Regulations, ROW Regulatory News, SFDA standards, Singapore medical device pilot, South Korea biologics, Taiwan AI/ML medical devices, TGA medical devices

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