Page 84 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

Reference: Drug Registration Guidance Document (DRGD), First Edition January 2013. Revised
November 2014 available from http://portal.bpfk.gov.my/index.cfm?&menuid=137.

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A Attachment B: Illustrative Substantiation Evidence
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Reference texts
a. Malaysian Herbal Monograph Volume 1, 2 or 3
b. NKEA Malaysian Herbal Monograph (www.globinmed.com).
c. Martindale, latest edition. The Complete Drug. Pharmaceutical Press, 2009.
d. The ABC Clinical Guide to Herbs. American Botanical Council.
e. WHO Monographs on Selected Medicinal Plants.
f. British Pharmacopoeia.
g. United States Pharmacopoeia.
h. Indian Pharmacopoeia.
i. Chinese Pharmacopoeia.
j. Natural Standards (www.naturalstandard.com)
k. Office of Dietary Supplements, National Institutes of Health – Dietary Supplement Fact
Sheets
l. (http://ods.od.nih.gov/Health_Information/Information_About_Individual_Dietary_Supple
ments.aspx)
Organizations
a. American Nutraceutical Association (www.ana-jana.org)
b. CODEX Alimentarius
c. Global Information Hub for Integrated Medicine (http://www.globinmed.com)
d. National Centre for Complementary and Alternative Medicine (http://nccam.nih.gov/)
e. Office of Dietary Supplements, National Institutes of Health (USA) (http://ods.od.nih.gov)
Reference regulatory authorities
a. Australia TGA
b. Chinese Health Authority on Chinese medicinal herbs
c. European Commission
d. Health Canada
e. United States FDA
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N Notes:
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1. This list is not meant to be exhaustive and will be reviewed from time to time.
2. The Authority will nonetheless conduct a detailed evaluation of the evidence included in
the report to ensure that the health claim is substantiated.
3. The Authority will be willing to consider review other than the listed above, if the
standards of evidence are consistent with those of the Authority.
4. All references must be current.

Reference: Appendix 4 Guideline on registration of health supplements. Drug Registration
Guidance Document (DRGD), page 201, First Edition January 2013. Revised November 2014.
Available from http://portal.bpfk.gov.my/index.cfm?&menuid=137.
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68 NIH Guidelines for Conducting Research in MOH, 2021