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

Ethics Committees registered with NPRA

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
 

Garis Panduan Institut Kesihatan Negara Mengenai Penyelidikan Di Institut Dan Fasiliti KKM (Pindaan 1/2015)

Surat Edaran Ketua Setiausaha Bil. 7 Tahun 2015 - Larangan Merakam Dan Menyebar Foto, Video Dan Maklumat Sensitif Mahupun Terperingkat Di Kementerian Kesihatan

Letter from Director General of Health to Sponsor on Management Fees for Industry Sponsored Research

Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bilangan 4/2015: Tatacara Prosedur Permohonan Berkaitan Penyelidikan set Stem dan Cell-Based Theraphies