Category: Biopharma

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

February 3, 2023
Biopharma

US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response...

BioTech, Biotech Regulatory News, EU Regulatory News, Pharma, Pharma Regulatory News, Regulatory Updates, USA Regulatory News

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

January 18, 2023
Biopharma

Asia Malaysia Guide for ADR reporters NPRA published guide for ADR reporters which included improving the quality of reports, checklist for ADR reporters. Guideline also includes laboratory...

Armenia Regulatory News, Asia Regulatory News, Baharain Regulatory News, BioTech, India Regulatory News, Malaysia Regulatory News, Pakistan Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Tanzania Regulatory News

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

January 4, 2023
Biopharma

EU EMA recommendation paper: Safety, data integrity key to decentralized trial conduct The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently...

BioTech, Europe Regulatory News, Pharma, Regulatory Updates, US Regulatory News

Biopharma – Europe, USA and Asia Regulatory News, Dec 2022

December 13, 2022
Biopharma

EU ICH M12 on drug interaction studies – Scientific guideline This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme-...

ICH: Guideline on Testing for Carcinogenicity of Pharmaceuticals, an Addendum

August 30, 2021
Biopharma

Over the course of drug development, it is important for sponsors to develop a scientifically robust strategy for carcinogenicity assessment that considers key biologic, pharmacologic, and toxicologic...

Addendum, Guideline on Testing for Carcinogenicity, Pharmaceuticals, Testing for Carcinogenicity of Pharmaceuticals

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...