ARQonJun 15, 20231 minMalaysia: DNA Test Requirement for Final Biologic Products Containing Materials of Animal OriginThe Drug Control Authority (DCA) updated the Drug Registration Guidance Document (DRGD) on the requirements of DNA testing for final...
ARQonJun 14, 20234 minUK: Medical Devices Registration Guidelines for Great Britain & Northern Ireland MarketsPrevious articles on The Windsor Framework discussed the human medicine deal arrangement between Great Britain and the Northern Ireland...
ARQonJun 12, 20231 minAustralia: ISO 13485 Draw To An Ending Phase for IVD Medical DevicesBeginning on 26 May 2023, the Therapeutic Goods Administration (TGA) has stopped accepting ISO 13485 certificates as supporting evidence...
ARQonJun 9, 20233 minSingapore: Laboratory Developed Tests (LDTs) Regulatory GuidelinesSingapore's Health Sciences Authority (HSA) has issued draft guidelines on Laboratory Developed Tests (LDTs) from 12 July 2022 until 12...