Tag: Pharma Regulatory News

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 – 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, meta description, NAFDAC alert, NMPA, Pharma Regulatory News, pharmaceutical campaign, PMDA, Regulatory Intelligence, SAHPRA, TGA updates

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

Pharma/Biotech – USA, Europe Regulatory News, Dec 2023 Vol. 1

Biopharma

USA Significant Public Response to FDA’s Proposed Oversight of Laboratory-Developed Tests The FDA has received over 2,100 comments on its proposed rule to regulate laboratory-developed tests...

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News, Viral Safety Evaluation

Pharma/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1

Biopharma

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining...

Biotech Regulatory News, Combination Products, EU Regulatory News, Marketing Authorisation, Pharma Regulatory News, Regulatory News, USA Regulatory News