Singapore HSA Updates Good Distribution Practice Guides for Therapeutic Products
In December 2023, HSA updated the following Good Distribution Practice (GDP) guides: – GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE …
Singapore HSA Publishes List of Acceptable Intake for Nitrosamines
In March 2020, HSA had communicated the regulatory requirement to conduct risk assessments for all therapeutic products containing chemically synthesized …
Singapore HSA Publishes Cosmetic Products Guidance on Adverse Effects Reporting, Product Defects and Product Recalls
In December 2023, HSA’s Complementary Health Products Branch publishes guidance on “Procedures for Reporting of Adverse Effects, Product Defects and …
Singapore HSA Announces Upcoming Regulatory Fee Revision for Health Products
Singapore’s Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and …
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 …
Minister of Finance of Vietnam Promulgates Circular Prescribing Fees in Medical Device Sector
Circular 59/2023/TT-BTC introduces regulations on fees in medical sector, and the collection, transfer, management and use thereof. Such fees in …
FDA PH Issues Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
Guidelines: A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification …
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 …