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 …
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 …
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 …
Vietnam MoH Issues Circular 41/2023/TT-BTC on Payment in Field of Pharmaceuticals and Cosmetics
On June 12, 2023, the Minister of Finance issued Circular 41/2023/TT-BTC on the rate, collection, payment, management and use in …
Singapore HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications
HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the …
China NMPA Extends Drug Submission Time for Supplementing Materials
On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission …
Hong Kong DOH Updates the List of Refence Countries for Registration of Pharmaceutical Products
Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical …
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