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
Regulatory News
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
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
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
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
Malaysia Issues New Guideline for Obsolete and Discontinued Medical Device
The Medical Device Authority (MDA) of Malaysia has recently issued a guidance document on 16 April 2020 for industry and healthcare professionals.
The document provides a guideline to the relevant parties
Field Safety Corrective Action (FSCA) launched by HSA Singapore
Effective from 6 April 2020, the Health Science Authority(HSA ) of Singapore has launched the new OSCAR system for Field Safety Corrective Action(FSCA).
Reporting and monitoring of FSCA have shifted from