Vietnam’s Updated Pharma Law Takes Effect July 2025 – Brings Greater Flexibility for Foreign Pharmaceutical Companies
Approved by the National Assembly on November 21, 2024, the updated pharmaceutical law is set to take effect from July …
Malaysia NPRA Updates Requirement of Safety Reporting in Clinical Trial Effective 30 April 2025
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has updated the clinical trial safety reporting requirements in the recently published …
Malaysia NPRA Updates Expansion Scope of The Requirements For The Bioequivalence (BE) Study Centres Accreditation And Exemption Of The BE Study Inspection Assessment
In line with current developments, the scope of BE study center inspection requirement has been expanded. The Immediate Implementation scope …
FDA Philippines publishes the Implementing Guidelines on the New Schedule of Fees and Charges for the Food and Drug Administration
The administrative order is issued to establish the new schedule of fees and charges for services rendered by the FDA …
Thai FDA published new guidelines on labelling requirements for medical devices
Thai FDA published new guidelines on labelling requirements for medical devices. These guidelines provide clarity on how labels should be …
Thai FDA Enforces New Compliance Standards for Medical Device Manufacturers and Importers
On September 6, 2024, Thai FDA released and amended the “Ministry of Public Health Notification, Re: Standards of Medical Devices …
Thai FDA issues guidelines on referencing existing documents, document transfer, and other cases for manufacturing and importing licensed and notified medical devices without agency evaluation
On September 19, 2024, Thai FDA releases the guidelines for submitting applications to manufacture and import Licensed and Notified Medical …
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 …