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 Therapeutic Products Guidances
As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, HSA …
Malaysia NPRA Update Guideline for Facilitated Registration Pathway (FRP)
Malaysia NPRA implement Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review with the aim of increasing the efficiency of …
Singapore HSA Updates Software Medical Device Registration Requirements
Singapore HSA updated “GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD” and “GN-18 R3 Guidance on …
Singapore HSA and Republic of Korea MFDS sign MRA on GMP for Medicinal Products
On 26th February 2024, Singapore’s Health Sciences Authority (HSA) and the Ministry of Food and Drug Safety (MFDS)of the Republic …
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 …