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 …
Singapore HSA Implements GMP Evidence for Drug Substance Manufacturers
As part of a continual regulatory enhancement to ensure the quality standard of therapeutic products supplied in Singapore, Singapore’s Health …
Singapore HSA Updates Advertisement Guidance for Therapeutic Products
Singapore’s Health Sciences Authority (HSA) updated EXPLANATORY GUIDANCE TO THE HEALTH PRODUCTS (ADVERTISEMENT OF SPECIFIED HEALTH PRODUCTS) REGULATIONS for Therapeutic …
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 …
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