Tag: Regulatory Updates

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

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

Biopharma

ASIA MALAYSIA Revised Guideline for Facilitated Registration Pathway (FRP) Malaysia’s NPRA has updated its Facilitated Registration Pathway (FRP) guideline. The revised framework now includes...

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

Revised GMP guidelines for Pharma in India

Biopharma

The government recently directed all pharmaceutical companies in the country to implement the revised Biopharma The Indian government has recently mandated all pharmaceutical companies to adopt...

Drug Manufacturing, Global Compliance, Good Manufacturing Practices, Pharmaceutical Industry, Quality Control, Regulatory Updates

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

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 – Sep 2021

Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates

Tag: Regulatory Updates

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

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

Revised GMP guidelines for Pharma in India

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

Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

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