Tag: Regulatory Updates

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

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

February 21, 2023
Biopharma

Asia India WHO calls for action after Asia-made medicines linked to 300 deaths Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough...

Asia Regulatory News, Australia Regulatory News, BioTech, India Regulatory News, Japan Regulatory News, Malayasia Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Singapore Regulatory News

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US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or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

Medical Devices – USA/Europe Regulatory Updates round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA