Resources

• Management Fees for Industry Sponsored Research
• Good Clinical Practice Requirement for Clinical Trial Investigators

Clinical Trials

• Malaysian Guidelines for Good Clinical Practice 4th Edition
• Regulatory Guidelines: Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, 7th Edition
• Conducting Research in Ministry of Health Institutions
• Conducting Research in Ministry of Health Institutions
• Guidelines for Good Clinical Practice (GCP) Inspection Second Edition
• Ethics Committees registered with NPRA 

Medical Device Studies

• Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation 

First-in-Human/ Phase I Studies

• Malaysian Phase 1 Clinical Trial Guidelines
• NPRA Circular
• Malaysian Guideline for Phase I Unit Inspection & Accreditation Programme

Stem cell Studies

• Circular – Research on Stem Cell & Cell-based Therapies

Bioequivalence/ Bioavailability studies

• Regulatory guidelines on Bioequivalence

Malaysia Medical Repository

Malaysia’s Registry Report

National Medical Research Register