Australia TGA changes ARTG Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices

From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian …

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Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR related changes to registered medical devices

With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact …

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Philippines FDA adopts the WHO Collaborative Registration Procedure (CRP) for the Accelerated Registration of WHO Prequalified Pharmaceutical Products and Vaccines.

This Administrative Order is issued to establish an accelerated review process for prequalified pharmaceutical products and vaccines, through the adoption …

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Thailand FDA issued an Announcement on Regulations, Procedures and Conditions for Providing Academic Documents for Medical Devices

The announcement was issued to confirm the standards of quality, efficacy and safety for medical devices for review by or …

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South Korea Releases New Law on Advanced Regenerative Medicine and Advanced Biopharmaceuticals

The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (abbreviation is “Advanced Regeneration Bio Act.”) and the subordinate …

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Australia TGA Launched New Early Scientific Advice Service

The Therapeutic Goods Administration (TGA) has launched a new initiative – the Early Scientific Advice service – that enables applicants …

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China NMPA rolls out Drug Information Traceability System for key drug products

On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular …

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Price Details to be Included for Import Licenses for Medicines in Sri Lanka

All applicants who submit applications to obtain import licenses for medicines in Sri Lanka should submit the application along with …

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China Releases Technical Guidance for Using Real-World Evidence(RWE) to Support R&D and Regulatory Review of Pediatric Drugs (Interim)

The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and …

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