On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification stipulated under subsection 61(5AB.
Pursuant to Subsection 61(5AA), the legislation permit
Regulatory News
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 (Act 737), the Medical Device Authority (MDA) has issued a
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 for clinical trials applicable for clinical trial import license applications
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.
The advertising of therapeutic goods will still be regulated by TGA
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.
The advertising of therapeutic goods will still be regulated by TGA
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 and improvement of the quality of drug clinical trials in
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 to pre-registration test results of natural products from private laboratories.
Directive
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 Pharmacy Services pertaining to physical testing for Lot release activities
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 raw materials of passive medical device products.
A medical device that