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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

Pharma- Asia, S America, MENA, ROW Regulatory News – July 2025

Biopharma

ARGENTINA ANMAT Opens Public Consultation on ICH E20 Guideline for Adaptive Clinical Trials The National Administration of Drugs, Food and Medical Technology (ANMAT) has opened a public consultation...

ANMAT guidelines, CDSCO digital submission, Clinical trial regulations, Drug safety alerts, Global pharmaceutical compliance, GMP extensions, July 2025 updates, Pharma Regulatory News, Regulatory harmonization, TGA compliance

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

Medical Device

BRAZIL Brazil Implements UDI Labeling for Class IV Medical Devices In July, Anvisa marks significant progress in the implementation of Unique Device Identification (UDI) in Brazil, requiring...

AI in Healthcare, EU MDR, HSA Singapore, IVD Devices, Medical Device Regulation, PMDA Japan, PSUR, Regulatory Compliance, SaMD, UDI Brazil

Align Regulatory Requirements with Project Management: Best Practices

Regulatory Intelligence

In the life sciences, pharmaceutical, and medtech industries, regulatory compliance isn’t just a box to check – it’s a critical function that shapes every phase of product development and market access....

compliance planning, medtech compliance, pharma project management, project management best practices, regulatory operations, regulatory project management, Regulatory Requirements, vistaar