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HSA Singapore Issues Updated Version of Regulatory …

WebThe new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances. Additional import and …

Actived: 8 days ago

URL: https://www.pharmatomarket.com/hsa-singapore-issues-updated-version-of-regulatory-requirements-for-clinical-trial-new-applications-and-subsequent-submissions/

Singapore HSA Releases Information on Import and

WebThe Health Sciences Authority (HSA) Singapore has provided some guidance on the import and supply of unregistered medical devices by the request of qualified practitioners in …

Category: Medical Go Health

Singapore HSA Publishes Document on Common Questions for …

WebThe Health Sciences Authority (HSA) Singapore has published a document on the common questions received for Generic Drug Applications in September 2021. The document …

Category: Health Go Health

Singapore HSA Publishes Finalised Medical Devices Product

WebThe Health Sciences Authority (HSA) Singapore published the latest Medical Devices Product Classification Guide in November 2021, to assist with the classification of certain …

Category: Medical Go Health

Singapore HSA Updates Guidance on Therapeutic Product …

WebThe Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic product …

Category: Health Go Health

Singapore MOH, HSA, and IHiS Publish Guideline on Artificial

WebThe Ministry of Health (MOH), the Health Sciences Authority (HSA), and the Integrated Health Information Systems (IHiS) have co-developed and published a guideline on …

Category: Health Go Health

Singapore HSA Publishes Revised Guidance on Health …

WebThe Health Sciences Authority (HSA) Singapore has published the latest guidance document on health supplements in March 2022. The working definition of health …

Category: Supplements Go Health

Singapore HSA Publishes Latest Guidance on Special Access Routes

WebThe Health Sciences Authority (HSA) Singapore has published the latest guidance document on special access routes (SAR), that provide a pathway for unregistered …

Category: Health Go Health

Field Safety Corrective Action (FSCA) launched by HSA Singapore

WebEffective 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 …

Category: Health Go Health

Singapore HSA Updates Guideline on Voluntary

WebHSA recently reviewed the newly implemented notification process, and HSA updated the Guideline on Voluntary Notification System for Health Supplements and Traditional …

Category: Supplements Go Health

Singapore HSA Announces Upcoming Regulatory Updates for …

WebSingapore Health Sciences Authority (HSA) sent an email to industry stakeholders, announcing that there will be upcoming amendments to the Health Products (Cosmetic …

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Singapore HSA and Republic of Korea MFDS sign MRA on GMP …

WebOn 26th February 2024, Singapore’s Health Sciences Authority (HSA) and the Ministry of Food and Drug Safety (MFDS)of the Republic of Korea signed a Mutual Recognition …

Category: Food Go Health

Australia TGA Publishes Guidance Document on Global Medical …

WebTherapeutic Goods Administration (TGA) Australia has published a guidance document on the Global Medical Device Nomenclature (GMDN) Terms, which discusses about the …

Category: Medical Go Health

Philippines FDA Issues Implementation Schedule and Guidelines …

WebThe Philippines FDA issued Circular no. 2021-002 on 4th January 2021, which contains the implementation schedule of the Administrative Order No 2018-002: “Guidelines …

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Philippines FDA Issues Circular on Revised Post-Marketing …

WebThe Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-020 to provide updated post-marketing surveillance (PMS) requirements for new drugs under …

Category: Food Go Health

NPRA Malaysia Issues Latest Drug Registration Guidance Document

WebNational Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in January 2022. One of …

Category: Health Go Health

Thailand Releases New Regulations and Guidelines on Report of …

Web5 documents have been released by the Ministry of Public Health and Thai FDA regarding revised reporting of device defects, Adverse Events Occurred to Consumers, and FSCA …

Category: Health Go Health

NPRA Malaysia Updates Variation Guideline for Pharmaceutical …

WebThe National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the second edition of the variation guideline for pharmaceutical products in July 2022.

Category: Health Go Health

Implementation of eCTD for Clinical Trial Applications in Canada

WebHealth Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 February 2020. This comes after …

Category: Health Go Health