• Master of Health Research Ethics (MOHRE)
  • mohre@um.edu.my
logo
logo

Resources

Compilation of Organizations, Laws, Regulations and Guidelines involving Research Standards

Categories 

2. Drugs, Biologics, and Devices

a) Drugs

Key Organization:

Legislation:

Regulations:

  • Regulation 7(1) or Regulation 18A of the Control of Drugs and Cosmetics Regulations 1984 (pg iii, ix,)
  • Regulation 15(5): Clinical Trial Exemption (CTX) (pg 1)
  • The Poison Regulations (Psychotropic Substances) 1989
     

Guidelines:

b) Biologics

Key Organization:

Guidelines:

c) Devices

Key Organization:

Legislation:

Regulations:

Guidelines:

3. Clinical Trial Registries

4. Research Injury

Key Organization:

Legislation:

Guidelines:

  • Malaysian Guideline for Good Clinical Practice, 4TH Edition, Section 5.8: Compensation to Subjects and Investigators

5. Social-Behavioral Research

Key Organization:

Guidelines:

6. Privacy / Data Protection

Key Organization:

Legislation:

Guidelines:

.

7. Human Biological Materials

8. Genetic Research

Key Organization:

Legislation:

Regulations:

Guidelines:

10. Research Standards

International Compilation of Research Standards 2021

Research Standards in Malaysia:

Last Update: 15/06/2022