To enhance the submission process, Malaysia NPRA has developed a screening package for New Drug Products and Biologics to provide clearer guidance and promote Good Submission Practice.
This tool is designed
Regulatory News
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, 2025. This is a crucial legal document detailing the registration
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 product classification applications via Google Forms, effective 1 May 2025.
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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 of Multiple Post-Approval Changes (PACs) of a Registered Pharmaceutical Product
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 1, 2025. These amendments introduce comprehensive changes aimed at enhancing
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 Guideline for Application of Clinical Trial Import Licence and Clinical
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 is as follows:
BE studies conducted at BE study centers during
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 and to provide guidelines for its implementation. The new fee
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 attached to medical devices intended for both home use and