Resources
First-in-Human/ Phase I Studies
Malaysian Guideline for Phase I Unit Inspection & Accreditation Programme, 1st Edition
Clinical Trials
Malaysian Guidelines for Good Clinical Practice, 4th Edition
Clinical Trials
Regulatory Guidelines: Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, 8th Edition
NIH Guidelines for Conducting Research in MOH, 3rd Edition
Clinical Trials
Malaysian Guideline for Good Clinical Practice (GCP) Inspection, Edition 2.1
Clinical Trials
Malaysia Guideline for BE Inspection, 1st Edition
Clinical Trials
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st Edition
Malaysian Guidelines On The Use Of Human Biological Samples For Research, 2015
Guide to BA/BE Centres in Malaysia, 2015
National Standards for Stem Cell Transplantation, 2018
National Standards for Cord Blood Banking and Transplantation, 2019
Malaysian Guidelines for Stem Cell Research and Therapy, 2009
Medical Device Studies
Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation, 1st Edition
A Guide to Conducting Clinical Trials in Malaysia, 1st Edition
Guideline for Herbal Medicine Research, 1st Edition
Malaysian Decentralised Clinical Trial (DCT) Guidance Document, 1st Edition