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. …
China to implement new Clinical Drug Quality Control Standards to harmonise GCP standards with ICH standards
In order to deepen the reform of the drug review and approval system, encourage innovation, and further promote the research …
NPRA of Malaysia Issues Directive on Pre -Registration Test Results of Natural Products
On 12 May 2020. National Pharmaceutical Regulatory Division (NPRA) has issued a directive by the Director of Services Pharmacy pertaining …
Malaysia Issues Directive for Physical Testing for Lot Release Activities for Vaccine and Plasma Products
On 12 May 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has announced a directive by the Director of …
NMPA of China Releases Evaluation Guideline for Raw Material Changes in Passive Medical Devices
On 19 May 2020, the National Medical Products Administration(NMPA) of China has formulated a document to evaluate the changes in …