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Directives & Circulars (GCP & GLP)

: Posted By Seksyen GCP & GLP; 22 September 2025; Jumlah paparan: 16888

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Document Name	Updated
Direktif berkenaan pengemaskinian keperluan Amalan Makmal Baik (Good Laboratory Practice, GLP) dan pelaksanaan pemeriksaan GLP study-specific ke atas fasiliti kajian luar negara bagi kajian keselamatan bukan klinikal untuk tujuan pendaftaran produk New Chemical Entity (NCE), biologik dan produk semula jadi dengan tuntutan terapeutik	17 September 2025
Had Maksimum bagi Yuran Pemprosesan dan Pemeriksaan Pusat Kajian Bioekuivalens (BE) Tempatan dan Yuran Pemeriksaan Amalan Makmal Baik (Good Laboratory Practice) ke Atas Fasiliti Bukan Klinikal di Malaysia	14 March 2016
Appointment of NPCB as Malaysian CMA for Monitoring Compliance to OECD Principles of GLP	1 June 2009
Directives related to Good Clinical Practice (GCP) / Phase 1 Unit Inspection & Accreditation Programme	-

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