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Medical Devices-Asia and ROW Regulatory News-Jan 2023

January 19, 2023
Medical Device

INDIA (CDSCO) Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer In order to...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Hong Kong Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices, Regulatory News, Saudi Arabia 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 News – Jan 2023

January 4, 2023
Medical Device

EUROPE MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 The guidance is applicable to medical devices which have been certified under...

Europe Regulatory News, Medical Devices, Regulatory News, USA 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-...

Global Regulatory Intelligence

December 13, 2022
Standards

The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes keep evolving and vary across markets. Establishing an effective regulatory...

Clinical Trials, Compliance Procedures, Health Authority, Manufacturing Requirements, Regulatory Intelligence