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) …

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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) …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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