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, …
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 …
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 Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
On 1st April 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene …
WHO: Singapore HSA, Korea MFDS, and Switzerland Swissmedic are the first three countries to be listed as WHO-Listed Authorities (WLA)
Korea MFDS, Singapore HSA and Switzerland Swissmedic are the first 3 countries to be listed as WHO-Listed Authorities (WLA). This …
FDA PH Issues Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
Guidelines: A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification …
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