Singapore HSA Implements Testing of Diethylene Glycol and Ethylene Glycol for Health Supplement and Traditional Medicines
Following World Health Organization (WHO) Alert regarding identified batches of falsified and fraudulently mislabelled drums of DOW USP/EP Propylene Glycol, …
Malaysia NPRA updates on Procedure and Criteria for Extending the Validity Period of the Bioequivalence Study Center (BE) and Ethics Committee registered with Drug Control Authority (DCA)
Based on current guidelines of BE study center inspections, BE study centers that have been inspected with satisfactory inspection results …
Singapore HSA Releases eCTD Specification Package for Implementation
“Singapore HSA’s Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective …
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
“On 7th Oct 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene …
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 …
FDA Philippines Publishes General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use
Administrative Order 2024-0013 establishes updated rules for the registration of pharmaceutical products and Active Pharmaceutical Ingredients (APIs) for human use, …
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 …
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