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Philippines: Comprehensive Framework for FDA LTO Application of Covered Health Product Establishments
On 22nd November 2024, the Department of Health of the Republic of the Philippines issued Administrative Order No. 2024-0015 , aiming to...
ARQon
Dec 17, 20242 min read
Thailand: Guidelines for Document Referencing, Transfers, & Compliance in Medical Device Applications (w.e.f. 20 September 2024)
In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or...
ARQon
Nov 20, 20242 min read
US: FDA’s DSCSA Exemptions, Waiver, & Exception
FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...
ARQon
Oct 29, 20242 min read
Philippines: DOH Guidelines for the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Exclusively for Export
On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for...
ARQon
Sep 11, 20243 min read
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