Category: Biopharma

Asia/ROW BioPharma Regulatory 2023 News/Updates recap

February 5, 2024
Biopharma

Asia China NMPA Tightens Regulation on Outsourced Manufacturing for MAHs NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing...

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 – Asia, ROW Regulatory News, Nov. 2023 Vol. 2

November 29, 2023
Biopharma

ASIA Malaysia Guideline for Facilitated Registration Pathway (FRP) NPRA revised Guideline for Facilitated Registration Pathway (FRP). The revised pathway includes registration schemes that...

Asia Regulatory News, BioTech, Conditional Approval, Facilitated Registration Pathway, Pharma, Regulatory Updates, ROW Regulatory News, Therapeutic Goods

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

November 9, 2023
Biopharma

USA FDA Publishes Two Final Guidance’s on Technical Specifications for Clinical Data The FDA published a pair of final guidance’s Friday meant to assist drug makers by providing technical...

Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2

October 26, 2023
Biopharma

ASIA Pakistan DRAP outlines pharma implications of Pakistan’s hazardous waste policy The Drug Regulatory Authority of Pakistan (DRAP) has shared information about how national guidelines on...

Asia Regulatory News, BioTech, Pharma, Regulatory Updates, ROW Regulatory News

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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...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