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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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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Taiwan FDA has Amended the Regulations for Good Clinical Practice in Consideration of ICH E6(R2)

The changes are with the consideration of the ICH E6(R2), key changes are: Article 23: sponsor’s subsidies and payments provided …

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Hong Kong Issues New Guidance for Cell and Tissue Products

The guidance issued to address the quality and safety of cell and tissue products other than ATPs, the Department of …

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UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium

The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate …

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