Page 82 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

2.8 References
3.0 NON CLINICAL STUDIES
3.1 Introduction
3.2 Nonclinical Pharmacology
3.3 Pharmacokinetics and Product Metabolism in
Animals
3.4 Toxicology study
3.5 Non-clinical study Report, tabulated overview
3.6 Conclusion
3.7 References
4.0 CLINICAL STUDIES (if any)
4.1 Introduction
4.2 Types of Studies
4.3 Clinical study synopsis, tabulated overview
4.4 Conclusion
4.5 References
5.0 EFFECTS IN HUMANS
5.1 Pharmacokinetics and Product Metabolism in
Humans
5.2 Safety and Efficacy
5.3 Marketing Experience
5.4 References
6. SUMMARY OF DATA AND GUIDANCE FOR
INVESTIGATOR
6.1 Mechanism of Action, administration
6.2 Use in treatment, duration of action
6.3 Precautions
6.5 Warnings
6.6 Potential Adverse Effects
6.7 Overdose
6.8 Directions for Storage, maintenance
9. APPENDICES (if any)

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A Attachment A: Definitions
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a) Traditional medicine (as defined under the Control of Drugs and Cosmetics Regulations
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1984):
Any product used in the practice of indigenous medicine, in which the drug consist solely of one
or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the
unextracted or crude extract form, and a homeopathic medicine. It shall not include any sterile
preparation, vaccines any substance derived human parts, any isolated and characterized
chemical substances.
Traditional medicines are allowed to have General and Medium claim. For general and medium
claim, it must be based on documented history of use and philosophy of the respective
traditional medicine
NRDHM HERBAL TEST ITEM FOR STUDIES Ver3.1 Mar2015 6

66 NIH Guidelines for Conducting Research in MOH, 2021