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...Regulatory News
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
read more...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
read more...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
read more...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
read more...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
read more...Chinese Pharmacopoeia 2020 draft approved by the Chinese Pharmacopoeia Commission
The Chinese Pharmacopoeia Commission has announced the Approval of Chinese Pharmacopoeia Version 2020 Draft during their 11th Executive Meeting.
The meeting which was held on 9th April 2020 introduced new and
read more...Pharmacovigilance Requirements Clarified by the FDA of the Philippines
The Department of Health of Republic of Philippines has issued a Circular No. 2020-003 effective on 26 February 2020 to provide clarification on the guidelines on pharmacovigilance obligations. The circular is
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