Malaysia NPRA Publishes Screening Package for New Drug Products and Biologics
To enhance the submission process, Malaysia NPRA has developed a screening package for New Drug Products and Biologics to provide …
Vietnam Ministry of Health Issues Circular on Registration of Drugs and Medicinal Ingredients for Circulation in Vietnam
On May 16, 2025, Vietnam Ministry of Health issued the Circular No. 12/2025/TT-BYT which will take effect from July 1, …
Malaysia Medical Device Authority (MDA) announces two key changes to the Product Classification Letter process.
1. Fully Online Application Process In line with its digital transformation efforts, MDA will fully transition to online submissions for …
FDA Philippines Issues Advisory on Streamlined Submission of Multiple Post-Approval Changes (PACs)
The Food and Drug Administration (FDA) Philippines released FDA Advisory No. 2025-0496 on 10 April 2025, titled “Allowing the Submission …
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 …