Tag: Regulatory Updates

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

January 31, 2024
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

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

Swissmedic Device/IVD Database Key Dates

November 3, 2023
Medical Device

Swissmedic now handles registration of economic operators, medical devices and in vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments...

IVD Regulations, Medical Device Compliance, Medical Device Manufacturers, Regulatory Updates, Swissmedic

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

Revised GMP guidelines for Pharma in India

September 26, 2023
Biopharma

The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards. Larger...

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

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