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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

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

November 28, 2023
Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News

Challenges, Benefits, and Future Trends in Compliance Intelligence

November 9, 2023
Medical Device

Regulatory compliance, also known as business compliance, pertains to an organization’s adherence to the laws, regulations, and other governing rules applicable to all entities. By utilizing...

Compliance Intelligence, Medical Device Industry. Compliance Intelligence, Regulatory Compliance

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

November 9, 2023
Biopharma

USA FDA Publishes Two Final Guidance’s on Technical Specifications for Clinical Data The FDA published a pair of final guidance’s Friday meant to assist drug makers by providing technical...

Modifications to Medical Device Registration in Mexico

November 8, 2023
Medical Device

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated the Guidance Document by defining types and impact of product or organizational changes...

COFEPRIS, Medical Device Regulations, Medical Devices, Mexico, Regulatory Guidelines

ANVISA Updates Importation Law: Key Changes

November 8, 2023
Standards

The introduction of RDC 751/2022 was significant for the Medical Device industry because it revised Brazil’s regulatory framework after two decades of validity. Despite the controversy surrounding...