Singapore HSA Updates Guidance Documents for CTGTP
In September/October 2024, HSA has re-organized and updated Cell, Tissue or Gene Therapy Product (CTGTP) guidance on Product Notification, Product …
Singapore HSA Updates Webpage on Nitrosamine Impurities in Medicines
Singapore Health Sciences Authority (HSA) has updated the webpages on nitrosamine impurities in medicines. The main webpage provides general information …
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
On 1st April 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene …
WHO: Singapore HSA, Korea MFDS, and Switzerland Swissmedic are the first three countries to be listed as WHO-Listed Authorities (WLA)
Korea MFDS, Singapore HSA and Switzerland Swissmedic are the first 3 countries to be listed as WHO-Listed Authorities (WLA). This …
Singapore HSA Implements GMP Evidence for Drug Substance Manufacturers
As part of a continual regulatory enhancement to ensure the quality standard of therapeutic products supplied in Singapore, Singapore’s Health …
Singapore HSA Revises Medical Device Adverse Events Reporting Guideline
Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update: – Included …
Singapore HSA Updates Medical Device Adverse Event Reporting Form
Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As …
Singapore HSA Updates Health Supplement & Traditional Medicines Labelling Guideline
HSA updates GUIDELINES FOR LABELLING STANDARDS OF HEALTH SUPPLEMENTS AND TRADITIONAL MEDICINES including clarification on labelling requirements on the name …
Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification
Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS …
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