Guidelines for Clinical Trial

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Document Name Updated
Malaysian Guideline for Application of Clinical Import Licence (CTIL) and Clinical Trial Exemption (CTX), 7th Edition Aug-2020
Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1  Dec-2020
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme Jun-18
Malaysian Guidelines for Good Clinical Practice 4th Edition Jan-18
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition Jun-16
Malaysia Guideline for BE Inspection, First Edition Oct-14
Malaysian Guideline for Safety Reporting of Investigational Products, First Edition Oct-14