[Updated] Malaysia’s Revision to Drug Registration Guidance Document in 2024, Affecting Health Supplement Registration

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has announced¹ the release of the third edition, eighth revision of the Drug Registration Guidance Document (DRGD)² on July 23, 2024, which will come into effect on July 31, 2024.

Please note that the revision of DRGD may affect various products such as new drug products, and natural products, including traditional medicines, herbal products, etc. However, this article only focuses on the amendment associated with health supplements. Details are as below.

Key Revisions

Amendment to the main body of DRGD

The evaluation timeline for health supplements with disease risk reduction claims has been added under "10.3 Evaluation Timeline for Product Registration". The updated evaluation timelines for health supplements are as follows.

No.	Product Category	Evaluation Timeline
(A)	Full evaluation
6.	Health Supplement with Disease Risk Reduction Claim	245 working days
(B)	Abridged evaluation
8.	Health Supplements* a) Single active ingredient b) Two (2) or more active ingredients * Applicable for: i) General or Nutritional Claims; and ii) Functional Claims (Medium Claims)	a) 116 working days b) 136 working days

Amendment to Appendix 6: Guideline on Registration of Health Supplements

New claims for 31 ingredients, including 15 new ones, have been added to "Table 17: Allowable claims for specific active ingredients in HS products". The 15 new ingredients and corresponding allowed claims are listed below.

Ingredients	Claims
Ingredients	General	Functional	Reduced risk reduction claim
Alpha Linolenic Acid	Helps in maintenance of good health	Supports heart health
Alpha Lipoic Acid	Helps in maintenance of good health	Antioxidant Helps to promote glucose metabolism Supports healthy nervous system
Astaxanthin	Helps in maintenance of good health	Antioxidant
Chromium	Helps in maintenance of good health	Contributes to normal macronutrient metabolism Helps to support healthy blood sugar level
Inulin	Helps in maintenance of good health	Helps to stimulate the growth of healthy bacteria (such as bifidobacteria) in the intestine
L-Glutathione	Helps in maintenance of good health	Antioxidant
L-Lysine	Helps in maintenance of good health	Source of essential amino acid for protein synthesis in the body
Lecithin	Helps in maintenance of good health	Supports liver health
Lycopene	Helps in maintenance of good health	Antioxidant Helps to support prostate health
Oenothera biennis (Evening primrose oil)	Helps in maintenance of good health	Helps in management of premenstrual syndrome (PMS)
Potassium	Helps in maintenance of good health	Supports healthy muscle function
Pyrroloquinoline quinone (PQQ)	Helps in maintenance of good health	Antioxidant
Saw Palmetto Berry	Helps in maintenance of good health	Support healthy urinary flow
Selenium	Helps in maintenance of good health	Antioxidant Helps to maintain healthy thyroid function Supports immune system
Vitis vinifera (Grape seed)	Helps in maintenance of good health	Antioxidant

Amendment to Appendix 20: Specific Labelling Requirements

10 new ingredients and their safety information are added to Appendix 20. Involved substances are ciprofloxacin, moxifloxacin, levofloxacin, ofloxacin, dapagliflozin, empagliflozin, canagliflozin, lithium, mefenamic acid, olmesartan.

Specific labeling requirements for existing ingredients are also revised, affecting ingredients hydrochlorothiazide, azacitidine, and hydroxychloroquine.

Amendment to Appendix 19: General Labeling requirements

“Immediate labels” under Item No. 15 “Name & content of preservative(s) where present”, Item No. 16 “Name & content of alcohol, where present”, and Item No. 17 “To declare source of ingredients derived from animal origin (active and excipient), including starting materials and gelatine” are now exempted for small labels (i.e., 5ml and less) used for ampoules/ cartridge, vials, eye drops, ear drops, and nose drops.

Amendment to Appendix 32: Explanatory Notes for Repackers

Definitions for "importer" and "wholesaler" have been added, and responsibilities for wholesalers have been clarified.

For more revisions, please click here.

Update on Jan 19: Third Edition, Seventh Revision

According to National Pharmaceutical Regulatory Agency (NPRA), Malaysia released the third edition, seventh revision of Drug Registration Guidance Document (DRGD) on Jan 19, 2024. The Revisions will take effect on Jan 31, 2024, except for four directives issued on Jan 18, 2024, which have been incorporated into the DRGD upon its release.

Please note that the revision of DRGD can affect various products such as new drug products, and natural products, including traditional medicines, herbal products, etc. However, this article only focuses the amendment associated with health supplement. Details are as below.

Key Revisions

1. Amendment of Section B: Product Registration Process (Effective on Jan 31, 2024)

Requirements for using shrink wrapping in promotional pack are newly established, i.e., to refer to “7.9.2 Promotional Pack".

2. Amendment of Appendix 6: Guideline on Registration of Health Supplements (Effective on Jan 31, 2024)

In terms of prohibited visual/graphics, labels that cannot bear prohibited marketing strategies like “Money back guarantee” are detailed to the labels for immediate container, outer carton, package insert and Consumer Medication Information Leaflet.

3. Amendment to Appendix 20: Specific Labelling Requirements (Effective on Feb 1, 2024)

For all products containing metformin, Appendix 20 requires the product’s package insert to be labeled with the warning "Metformin may reduce vitamin B12 serum levels", relevant precautions and the corresponding adverse effects. The information related to corresponding side effects are also required to be labeled on Consumer Medication Information Leaflet.

Two new ingredients are added to Appendix 20. They are imatinib and rivastigmine. For products containing imatinib or rivastigmine, they shall follow corresponding labeling requirements newly proposed in this Revision.

4. Amendment to Appendix 21: Special Conditions for Registration of a Particular Product or Group of Products (Effective on Jan 18, 2024)

Previous DRGD version stipulates that “Products containing midazolam are restricted for use in government and private hospitals and specialist clinics only.” Now this Revision changed the product's scope into “Products containing midazolam in table form …”.

Detailed revisions can be read at List of Updates for Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision, January 2024.

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