Health Supplements Registration in Malaysia by Jeevanraj Rajagopal, 16 June 2011

1. HEALTH SUPPLEMENTS
REGISTRATION IN MALAYSIAREGISTRATION IN MALAYSIA
16 JUN 2011
JEEVANRAJ RAJAGOPAL
Biro Pengawalan Farmaseutikal Kebangsaan
Kementerian Kesihatan Malaysia
Tel:03-78835530 Email:jeeven@bpfk.gov.my

2. Contents
BPFK Introduction
Definition
Health Supplement
Registration CriteriaRegistration Criteria
Food/Drug Interface
Conclusion

3. ORGANISATION CHART MINISTRY OF HEALTH MALAYSIAORGANISATION CHART MINISTRY OF HEALTH MALAYSIA
MINISTER
PARLIMENTARY SECRETARY
DEPUTY MINISTER
SECRETARY GENERAL
DIRECTOR GENERAL OF HEALTH
Deputy
Secretary
General
(Finance)
Accounts
Senior Director
(Pharmacy)
Director
(Dental)
Deputy Director
General
(Research & Technical
support)
Deputy Director
General
(Medical Services)
Deputy Director
General
(Public Health
Services)
Deputy Secretary
General
(Management)
Legal
Advisor
Internal
Audit
Corporate
Policy &
Industrial
Human
Resources
Epidemiology
Disease Control
Pharmaceutical
Care Management
Medical
Development Planning &
Development
Policy &
Development
Finance
Procurement &
Privatisation
Industrial
Health
Public Relations
Unit
Training
Competency
Information
Technology &
Communicatio
n Division
Management
Services
Disease Control
Food Quality &
Safety Division
Health
Education
Medical
Practice
Tele-
Health
Integrated
Health
Nursing
Division
Development
Engineering
Medical Device
Control
TCM
Development
Dental
Practice
Family
Health
Licensing &
Enforcement
National
Pharmaceutical
Control Bureau
(NPCB)
IMR IKPAV IPSK IKU IPK CRC
INSTITUTE / STATE MEDICAL HEALTH DIRECTOR
NATIONAL
INSTITUTE
OF HEALTH
(NIH)
SECRETARIAT

5. Where are we
located?
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Jalan Universiti, P.O.Box 319,
46730 Petaling Jaya, Selangor
Malaysia
Tel : 603-7957 3611
Fax: 603-7956 2924/ 7958 1312

6. CONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICS
ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)
Sub Regulation 7(1)
No person shallNo person shall
-manufacture
-sell
-supply
-import
-possess
-or administer any product

7. CONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICS
ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)ACT 1984 (REVISED 2006)
unlessunlessunlessunless::::
the product is a registered product,
andandandandandandandand
the person holds the appropriate license
required & issued under the CDCR

8. Registration and Licensing Activityand Licensing Activity
under theunder the Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)Drug Control Authority (DCA)
)
MALAYSIAMALAYSIAMALAYSIAMALAYSIAMALAYSIAMALAYSIAMALAYSIAMALAYSIA
)
The NPCB acts as theThe NPCB acts as theThe NPCB acts as theThe NPCB acts as the SecretariatSecretariatSecretariatSecretariat to the DCAto the DCAto the DCAto the DCA

9. RegistrationRegistrationRegistrationRegistration
PharmacovigilancePharmacovigilancePharmacovigilancePharmacovigilance
TrainingTrainingTrainingTraining
MAIN FUNCTIONSMAIN FUNCTIONS
SurveillanceSurveillanceSurveillanceSurveillance
AnalysisAnalysisAnalysisAnalysis
LicensingLicensingLicensingLicensing

10. PRODUCT
REGISTRATIONREGISTRATION

11. OBJECTIVE OF REGISTRATION
To ensure that all
pharmaceutical product
which is registered
under DCA is evaluated
on theon the
safety,
quality and
efficacy

12. Product RegistrationProduct Registration
Fasa 1 Fasa 2 Fasa 3 Fasa 4 Fasa 5
Bioteknologi
Produk Veterinari
Produk Baru
Registration
1988
(OTC)
Registration
Jan 1992
(Traditional
Medicine)
Registration
Feb 2002
(Cosmetics)
Notification: 1
January 2010
Registration
August 2007
(Veterinary)
Registration
Aug 1985
(Prescription
Drugs)
Licensing
May 1987
Licensing
1992
Licensing
Manufacturers
Importers
Jan 1999
Licensing
Jan 2004
Licensing
Licensing
Wholesalers
July 2002
Surveillance
1999
Surveillance
2004
Surveillance
Bahan Aktif
Farmaseutikal
Surveillance
1995
Surveillance
1995

13. Registration Fees
. Product Classification Processing
Fees (RM)
Analysis fees
(RM)
Total Fees
(RM)
1. Health Supplement 1000.00 Single active
ingredient:
2,200.00
1,200.00
Two or more
active
ingredients :
2,000.00
3,000.00
2. For Export Only Health
Supplement
1,000.00 1,000.00

14. Registration criteria
- Applicant must be a locally
incorporated company,
- and be authorized in writing by the
product owner to be the holder of theproduct owner to be the holder of the
registration certificate and be
responsible for all matters pertaining
to the registration of the product

15. Product Registration
REGISTRATION APPLICATION
On-line Quest 3 System

16. Registration procedure- online
www.bpfk.gov.my

17. Registration procedure- online
www.bpfk.gov.my

18. Applicant reply to KPP regarding
Incomplete documentation
Screening by Head of Health
Suplemen Unit (KPP)
Payment will be asked to be done
Applicant
Further evaluation by Health
Supplement Officer
*
Reply Through Quest 3
to comply to our
requirements
Complete
Incomplete
REGISTRATIONPROCESS
Meeting Drug Control
Authority
Meeting ‘Jawatankuasa Kerja
Pendaftaran’
Issue registration certificate
*
Complete
Approve
Letter of
rejection to
applicant
Reject
REGISTRATIONPROCESS
FLOWCHART

19. • Pharmacetical
Safety, Quality, Efficacious
Registration Criteria
• Health Supplement/
Traditional
Safety and Quality
• Cosmetics
Safety and Quality

20. Products Particulars Product Formula
Registration Criteria
Product Name
Product Description
Dosage Form
Dosage
-Active
ingredient
-Ban item
Labelling Requirement Packing Particulars
Manufacturer
Name and address
-CPP
_GMP
-CFS
-Compulsory
labelling
requirement
-Additional
Warning/
Precaution
Dosage
-Pack size
-Type of
container
-Ban item
-Excipient

21. Health Supplement Definition
Health Supplements shall
means product that are
intended to supplement
the diet taken by mouth in
forms such as pills,forms such as pills,
capsules, tablets, liquids
or powders and not
represented as a
conventional food or as a
sole item of a meal or the
diet

22. Health Supplement
Registration
22

23. Product to be registered under
Health Supplement
The dietary ingredients in these
products may include:
Vitamins, Minerals, Amino
Acids
Natural substances of
plant/animal originplant/animal origin
Enzymes, substances with
nutritional /physiological
function
and/or
Combination with selected traditional
substance:
(eg: Bee Pollen, Blue Algae,
Chlorella, Chlorophyll, Alfafa,
Spirulina, Garlic)

24. )

25. List B: List of Active ingredients that are allowed
to be combined with active
ingredients in List A
1. Acerola
2. Aloe vera
3. Allium sativum (Garlic)
4. Bee pollen
5. Bee propolis
6. Borago officinalis (Borage oil)
16. Medicago sativa (Alfafa)
17. Pine bark (pycnogenol)/ Pinus miritus
(pinus massoniana, pinus pinaster
18. Pine pollen
19. Propolis
20. Rosa canina
21. Rose hips
22. Rosmarinus officinalis
23. Royal jelly6. Borago officinalis (Borage oil)
7. Chlorella (Chlorella pyrenoidosa,
Chlorella sorokianiana, Chlorella
vulgaris)
8. Chlorophyll
9. Camellia sinensis
10. Evening primrose oil/Oenothera
biennis
11. Ganoderma
12. Ginseng/ Panax ginseng
13. Hordeum Vulgare (Barley)
14. Kelp/ Laminaria sp.
15. Linum usitatissimum (Flaxseed oil)
23. Royal jelly
24. Seaweed
25. Shark cartilage
26. Shark liver oil
27. Spirulina (Spirulina platensis)
28. Tagetes erecta (Marigold)
29. Vitis vinisfera (Grape seed extract)
30. Wheat Germ Oil
31. Wheat grass

26. HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
SAFETY
Upper daily limits set for some vitamins and
minerals (Appendix 9 in Drug Registration
Guidance Document)
New active ingredients / new doseNew active ingredients / new dose
New combination
Non permitted/ banned ingredients
Product Information
Warnings/precautions/drug interactions/adverse
effects

27. UPPER DAILY LIMITS OF VITAMINS AND MINERALS
FOR ADULTS ALLOWED IN DIETARY SUPPLEMENTS
1. Vitamin A 5000 IU
2. Vitamin D 400 IU
3. Vitamin E 400 IU
4. Vitamin B1 (Thiamine) 300mg
5. Vitamin B2 (Riboflavine) 30mg
6. Vitamin B5 (Pantothenic acid) 200mg
7. Vitamin B6 (Pyridoxine) 100mg
8. Vitamin B12 (Cyanocobalamin) 150mcg
9. Vitamin C (Ascorbic Acid) 1000mg
10. Folic acid 15mg 15mg10. Folic acid 15mg 15mg
11. Niacin (Nicotinic Acid) 500mg
12. Niacinamide (Nicotinamide) 250mg
13. Biotin 40mg
14. Calcium 1400mg
15. Copper 2mg
16. Iodine 300mcg
17. Iron 20mg*
18. Magnesium 400mg
19. Manganese 5mg
20. Phosphorus 1400mg
20. Selenium 300mcg
21. Zinc 25mg
(Note: * For pre and antenatal use, as part of a multivitamin and mineral
preparation, levels higher than the 20mg limit established for adults may be
permitted at the discretion of the DCA)

28. Supportive documents:
-GRAS status (USFDA)
-Status at other reference countries like
health canada, therapeutics goodshealth canada, therapeutics goods
administration (TGA)
-Standard reference on the indication and
-Safety use as a health supplement product
-Journals

29. Non permitted/ banned ingredients
•Vitamin K
•Conjugated Linoleic acid (CLA)
•Glucosamine
•Boric acid/ borax
•Banned probiotics:
oBACILLUS COAGULANS (LACTOBACILLUS SPOROGENES)oBACILLUS COAGULANS (LACTOBACILLUS SPOROGENES)
oENTEROCOCCUS FAECIUM
oENTEROCOCCUS FAECALIS
(Potential pathogenic bacterium, inadequate evidence of safety to
justify their use as probiotic)
(Appendix 6 Drug Registration Guidance Document)

30. Non permitted/ banned ingredients

31. Those combinations are not allowed
to be registered.
Combination of Vitamin(s) with other drugs
•Vitamin (s) + Appetite Suppressant•Vitamin (s) + Appetite Suppressant
•Vitamin (s) + Corticosteroid
•Vitamin (s) + Analgesic
•Vitamin (s) + Laxative
•Vitamin (s) + Slimming Agents
•Vitamin (s) + Vitamin K
(Appendix 6 Drug Registration Guidance Document)

32. Warning labels (refer appendix 2
DRGD)
Bee Pollen/Propolis
Ginseng
AlfalfaAlfalfa
Aspartame
Arginine

33. Warning labels (refer appendix 2 DRGD)
Compulsory:
L-ARGININE
Arginine is not recommended for patients following a heart attack
‘
CHITOSAN, CHONDROITIN, FISH OIL
Derived from seafood
GINSENG
safe use of ginseng in pregnant women and children has not been established
do not exceed the stated dose
safety on long term use has not been established
ASPARTAME
Unsuitable for phenylketonurics

34. PRODUCT INFORMATION:
Warnings/precautions/drug interactions/adverse
effectsALFALFA (MEDICAGO SATIVA)
This product contains Alfalfa (Medicago sativa).
Individuals with a predisposition to systemic lupus erythematosus should consult their
physician before consuming this product
BEE POLLEN
This product contains Bee Pollen and may cause severe allergic reactions, including
fatal anaphylactic reactions in susceptible individuals.fatal anaphylactic reactions in susceptible individuals.
Asthma and allergy sufferers may be at greater risks
ROYAL JELLY
This product contains royal jelly and may cause severe allergic reactions including
fatal anaphylactic reactions in susceptible individuals
Asthma and allergy sufferers may be at the greater risks
(Appendix 3 Drug Registration Guidance Document)

35. INGREDIENTS DERIVED
FROM SEAFOOD
Additional data required:
-Dioxin level certificate/ results analysis
(finished product/ raw active ingredient)
-The certificate must have specification and results

36. PRODUCT CONTAINING PLACENTA
Hormone test certificate:
-Must have specification of detection limit and results, mainly on estrogen,
progestrogen and testosterone
Additional data required:
progestrogen and testosterone
Letter of declaration :
-Additional letter from the manufacturer stating that the placenta in the
formulation is hormone free, which means are no added hormone

37. LABELING REQUIREMENTS

38. Non Permissible Name

39. HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Imported product:
- Certificate of Pharmaceutical Product or
- Certificate of Free Sale- Certificate of Free Sale
- GMP Certificate: Have to comply with current Good
Manufacturing Practices (GMP) requirements
(infrastructure /facilities, personnel, processes and
controls)
Local product:
- Manufacturer’s Licence

40. HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Should conform to set standards of quality:
-Product Specifications: Assay
-Raw materials (CoA)
-Finished Product Quality Control (FPQC)-Finished Product Quality Control (FPQC)
-Stability Data
-Heavy metals : Pb, Hg, As, Cd
-Microbial Limit Test: bacteria, fungi, specified
microorganism
-Disintegration test, Weight of Uniformity Test
-Manufacturing process
-In-process Quality Control (IPQC)

42. Specifications:
Mercury - not more than 0.5 ppm
Heavy Metal Test
Arsenic - not more than 5.0 ppm
Lead - not more than 10 ppm
Cadmium - not more than 0.3 ppm

43. Lab Result
- example-

44. HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Indication:
- Allowed to be indicated as “Dietary / Food/ Health Supplement”.
Claims:
-Supplements may not bear disease claims (ie capable of curing, treating-Supplements may not bear disease claims (ie capable of curing, treating
or preventing disease); either explicit or implied.
-Functional claims which describe the physiological role of the nutrient in
normal functioning of the body may be permitted
-Claim for active ingredients and not for product
Refer to Appendix 9 DRGD

45. Functional Claims

46. Pack Size
Maximum pack size allowed for tablets, pills, capsules is based on
daily dosing for a quantity not exceeding six (6) months usage.
Shape of tablet
Animal shapes tablet are not allowed.
Sustained release and Timed release dosage form
Protocol of analysis, In- Process Quality Control (IPQC), Finished
Product Specification (FPQC) and Certificate of Analysis (COA)
should be submitted.

47. ‘Food –Drug
Interface’
47

48. Food? Drug?
Classification Guideline
Product
“Food-Drug Interface”

49. Classifications of Product is through “Food-Drug Interface”
by : Food-Drug Interface classification committee
Product “Food-Drug
Interface”
- National Pharmaceutical Control Bureau, NPCB
- Food Safety and Quality Division, FSQD
Ministry Health of Malaysia
Appendix 10 ; Guide to classification of Food-Drug Interface Products
“ Drug Registration Guidance Document ”

50. Guide to Classification of Food-Drug Interface Products
(Guide to determining if a product is to be regulated by the NPCB/FSQD)

51. Produk “Food-Drug
Interface”
BKKM
• >80% - food base
ingredient
BPFK
• <80% - food base
ingredientingredient
• <20% - ingredients like
vitamin, mineral
ingredient
• > 20% active
ingredient
Product Classification Form : BPFK-003

52. Key Points For Classification
When polysaccharides (e.g ;maltodextrin) are present in capsule form,
they shall be considered as excipient and shall not be included in
determining the percentage of active ingredient
Permitted probiotics when present by itself singly or in combination in
capsule or tablet form shall be regulated under BPFK and shall contain
minimum 106 viable cells/g of the viable cells for each strain.
Permitted probiotics when present in foods shall be treated as food
ingredients and shall contain minimum 106 viable cells/g of the viable
cells for each strain.
Product Classification Form : BPFK-003

53. Key Points For Classification
All protein based ingredients (e.g – casein, whey, soy protein) shall be
treated as food ingredients even though they are present in
pharmaceutical dosage form.
Any foods or combination of foods may be regulated under BKKM even
though they are present in capsule, softgel, tablet or sachet is to be
decided together with the intended use.
Capsules containing one or more natural ingredients that are not
traditionally used as food shall be regulated under BPFK
Oils that are not traditionally used as food or combination e.g evening
primrose oil, garlic oil, fish oil, flaxseed oil and grapeseed oil in capsule
or softgel shall be regulated under BPFK.

54. Key Points For Classification
Substances listed in the prohibited ingredient list of the Drug Registration
Guidance Document (DRGD) shall not be permitted for used in any
products.
Dietary fibre includes inulin, fructooligosacharrides,
galactooligosacharrides, polydextrose, acacia gum, oat soluble fibre,
resistant dextrose and resistant maltodextrine
The following ingredients do not follow 20: 80 Decision Tree:
-Plant stanol/ sterol & esters (>3.5g/day under BPFK)
Borang pengkelasan produk: BPFK-003
-Plant stanol/ sterol & esters (>3.5g/day under BPFK)
-Psyllium Husk (>3.5g/day under BPFK)
-Schedule Poisons (BPFK)
-Probiotics more than 106 viable cell/g

55. Miscellanous
Tea Sachet
Herbal tea product in sachet form is regulated under circular of Drug
Control Authority (bil 11) in bpfk/02/5/1.3 in which herbal tea in sachet
that has medical claim only will be controlled and need to be registered
with Drug Control Authority (DCA).
Lozenges
The industrial company is not allowed to put the word ’lozenges’ on food
Borang pengkelasan produk: BPFK-003
The industrial company is not allowed to put the word ’lozenges’ on food
product.

56. Reasons for product to be rejected
Incomplete Document
Contains banned ingredientsContains banned ingredients
Does not comply to GMP
Inappropriate GMP authority

57. REFERENCESReferencesReferences

58. REFERENCES

59. Registered Product
59

60. Registered Product
Registration Number: eg. MAL100604653X (with C, R, S, (E)
Product holder is allowed to do certain changes on the registered
product through ‘variation’ through online.
Registered product will be check through surveilans
Registered product validity: 5 yearsRegistered product validity: 5 years
Reregistration need to be done every 5 years, to ensure the registered
status. Six months before the validity of registration expires need to be
submitted.

61. SUMMARY
61

62. Policy
-change of policy time to time
New technology/ era
-Have to be updated, eg: bilayer technology-Have to be updated, eg: bilayer technology
New invention by applicant
-New dosage form, extended release/slow
release, increased standards
-Client charter on time to register ,eg: single
ingredient 60 working days, combination
ingredient 90 working days

63. - Pharmaceutical Services Division :
www.pharmacy.gov.my
- National Pharmaceutical Control Bureau :
63
- National Pharmaceutical Control Bureau :
www.bpfk.gov.my