China Publishes Guidance for Medical Device Good Manufacturing Practice On-Site Inspections on Standalone Software
On 29 May 2020, the National Medical Products Administration ( NMPA) of China has formulated a “Guiding Principles for On-site …
NMPA Issues Guideline on Management and Archiving of Required Documentation for Drug Clinical Trials
The National Medical Products Administration (NMPA) of China has released a circular as a guiding principle for the preservation of …
Malaysia Issues Circular on Transition Period for Medical Device Advertisement
On 20 May 2020, the Medical Device Authority (MDA) of Malaysia has issued a circular pertaining to the transition period …
China Releases Guidelines for Preparing Pharmacovigilance Outsourcing Agreement (Interim)
4 June 2020, The China National Centre for Adverse Drug Reaction (ADR) Monitoring releases guidelines applicable for drug marketing license …
TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods
On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification …
Malaysia Issues Guidance Documents on Complaint Handling and Mandatory Problem Reporting for Medical Devices
In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act …
NPRA of Malaysia Implements Fast-Track Review for Clinical Trials
On 18 June 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has published a circular announcing a fast-track review …
TGA Waives Pre-Approval for Medicine Advertisements in Specified Media
Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media. …
TGA Waives Pre-Approval for Medicine Advertisements in Specified Media
Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media. …