Tag: Pharma Regulatory News

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

September 3, 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

August 6, 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

December 7, 2023
Biopharma

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT),...

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

October 10, 2023
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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...

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

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

September 8, 2023
Biopharma

USA Guidance’s Released on EPCIS Standard for DSCSA Compliance, Pulmonary Disease Drug Development The FDA recommends that “trading partners” use the Electronic Product Code Information...

Biotech Regulatory News, EU Regulatory News, Good clinical practice, Pharma Regulatory News, Regulatory News, Risk management, USA Regulatory News

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

August 3, 2023
Biopharma

US FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees Increase While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar...

Biotech Regulatory News, EU Regulatory News, marketing authorization, Pharma Regulatory News, post marketing requirements, Regulatory News, USA Regulatory News