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
Regulatory News
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
China NMPA Releases “Adverse Event Reporting Guidance for Medical Device Registrants”
On 03 April 2020, the NMPA of China has recently issued Guidelines for Medical Device Registrants to carry out adverse event monitoring on medical devices. The guidance was issued following
Philippines issues New Circular on Registration of Human Influenza Vaccines
The Department of Health of the Philippines has recently issued Circular No: 2020-002 on 06 February 2020 pursuant to the Food, Drugs and Cosmetics Act.
The circular is intended to provide