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ARQon
Dec 172 min read
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...
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ARQon
Nov 202 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...
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ARQon
Oct 292 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...
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ARQon
Sep 113 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...
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