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
Regulatory News
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
EPD Hong Kong Issues Guideline for Unserviceable / Expired Medicines
On May 2020, The Environmental Department (EPD) of Hong Kong has published a guideline with procedures on disposing of unserviceable or expired medicines for licensed pharmaceutical traders.
The pharmaceutical traders shall
TGA Australia Updates Regulatory Guidelines In Replacement of ARGCM V8.0
The Therapeutic Goods Administration (TGA) of Australia has published in May 2020, new guidelines to replace the existing Australian Regulatory Guidelines for Complementary Medicines (ARGCM) V8.0 for registered complementary medicines
China Issues Three Technical Guidelines for Consistency Evaluation of Generic Chemical Injections
On 15 May 2020, the Drug Evaluation Centre of China (CDE) has issued guidelines used to evaluate the consistency of efficacy and quality of generic chemical injections.
One of the guidelines
Singapore publishes Summary Reports of Benefit-Risk Assessment for NCE/NBE online
Effective from June 2020 onward the Health Sciences Authority, Singapore will be publishing the Summary Reports of Benefit-Risk Assessments for new biological and chemical entities. The pilot initiative will boost
Australia TGA Updates Public Information on Inactive Ingredients in Medicine Formulations
30 April 2020, The Therapeutic Goods Administration (TGA) of Australia has announced the release of important formulations on biological products and medicines on its website.
The intention of the release was