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 …
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore HSA’s ongoing initiatives to improve regulatory efficiency and enhance clarity in HSA’s regulatory requirements and processes, …
Singapore HSA Revises Guideline on Consignment Importation of Therapeutic Product
Singapore HSA revised Guideline on Import a Therapeutic Product on Consignment Basis. The revised guideline provides further clarity to the …
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