Tag: BioTech

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

September 12, 2023
Biopharma

ASIA Pakistan Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021 The Ethical Marketing to Healthcare Professionals Rules have been notified...

Asia Regulatory News, BioTech, ECTD Validation, Good Manufacturing Practice, Pharma, Post Marketing Surveillance, Regulatory Updates, ROW Regulatory News

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

July 26, 2023
Biopharma

ASIA Singapore Guidance on therapeutic product registration in Singapore This guidance document describes the procedures and requirements for submitting an application to register a therapeutic...

Asia Regulatory News, BioTech, New Molecular Entities, Pharma, Regulatory Updates, ROW Regulatory News, Swissmedic, Therapautic Product

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

June 21, 2023
Biopharma

ASIA India India starts mandatory tests of exported cough syrups after child deaths India will require manufacturers of cough syrups to acquire a Certificate of Analysis (CoA) from a designated...

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

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

April 20, 2023
Biopharma

ASIA Malaysia Declaration of Worldwide Registration Status for Generic Medicines in QUEST System All new applications for Generic Medicines (Prescription-Full) shall declare...

ANVISA, Asia Regulatory News, BioTech, Chemistry, eCTD, Manufacturing and Control (CMC), Pharma, Regulatory Updates, ROW Regulatory News