In March 2020, HSA had communicated the regulatory requirement to conduct risk assessments for all therapeutic products containing chemically synthesized drug substances to identify any potential risk of nitrosamine impurities.
Where
Regulatory News
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 Product Recalls for Cosmetic Products”. The document provides guidance on
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 efficacy. There are fees in place to help cover the
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 marks a significant milestone for the 3 countries that have been
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 the medical sector include:
a) Fees for processing of applications for
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 Portal System at https://verification.fda.gov.ph and shall be updated monthly.
B. All MAHs
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 Sciences Authority (HSA) will roll out a transition plan for
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 new section regarding Adverse Event Investigation
– Listed regulatory actions that HSA
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 a management committee member of the International Medical Device Regulators