Resources

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

Clinical Trials

• A Guide to Conducting Clinical Trials in Malaysia
• Malaysian Guidelines for Good Clinical Practice 4th Edition
• Regulatory Guidelines: Malaysian Guideline for Application of CTIL and CTX, 8.1th Edition 2025
• Circular Letter for Conducting Research in Ministry of Health Institutions
• NIH Guidelines For Conducting Research In Ministry of Health Institutions & Facilities 3rd Edition 2021
• 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 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

Sales & Services Tax

• Frequently Asked Questions

CRM Clinical Trial Agreement System

Malaysia Medical Repository

Malaysia’s Registry Report

National Medical Research Register