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
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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
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 Guidelines for Complementary Medicines (ARGCM) V8.0 for registered complementary medicines
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 efficacy and quality of generic chemical injections.
One of the guidelines
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 new biological and chemical entities. The pilot initiative will boost
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 and medicines on its website.
The intention of the release was
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) registration conditions.
The applicants need to fill up 9 fields in
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) registration conditions.
The applicants need to fill up 9 fields in
read more...New advertising guideline by Japan for IVD Marketing Information
On 01 April 2019, the Japan Association of Clinical Reagents Industries (JACRI) issued a guideline for marketing information on In-Vitro diagnostics(IVD). The manufacturers, contractors/partner companies (including co-promotion partner companies) need
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