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Document Name Updated Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia - Second Edition (September 2025) 19 Sep 2025
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Dokumen Muat Turun Kemaskini Pekeliling Berkenaan Penggunaan Kod QR oleh Pemegang Pendaftaran Produk (PRH) Bagi Tujuan Pengedaran Additional Risk Minimisation Materials (aRMM) Kepada Anggota…
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Document Name Updated GUIDELINE FOR DRUG-MEDICAL DEVICE AND MEDICAL DEVICE-DRUG COMBINATION PRODUCTS (5th EDITION) Jan-2023
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Document Name Updated GUIDANCE-DOCUMENT-AND-GUIDELINES-FOR-REGISTRATION-OF-BIOSIMILARS-IN-MALAYSIA-Dec-2023_Second-Edition Dec-2023
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Document Name Updated Guideline For Facilitated Registration Pathway For more information regarding registration application submitted via Facilitated Registration Pathway (FRP), kindly refer to the…
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Document Name Updated Guidelines on Conditional Registration for New Chemical Entities and Biologics in Malaysia - 2nd Edition - December 2020 25 May 2022
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Document Name Updated GUIDANCE AND REQUIREMENTS ON CONDITIONAL REGISTRATION OF PHARMACEUTICAL PRODUCTS DURING DISASTER 4 June 2022
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Document Name Download Updated Appendix 4: Guidelines On Registration Of Biologics DOWNLOAD July 2021
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Document Name Download Updated Site Master File (SMF-BE) For Blood Establishments in Malaysia DOWNLOAD Jun-2016
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