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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

Singapore launches new E-FORM for Therapeutic Products(TP)

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) …

read more...

Singapore launches new e-form for post-approval Registration Conditions of Therapeutic Products

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) …

read more...