Spotlight on Australia: Life and Health Sciences

Key Points 01 TGA follows a European approach 02 230 03 and dossier (ICH, PIC/S, BP/EP/USP are largely accepted, on occasion with Australian additions) Increasing use of international collaboration and reliance pathways for new products and generics. Timelines for prescription medicines are reliable and shortening, improvements for OTCs and devices are still being implemented MyMedical DEPARTMENT

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