HEALTH SUPPLEMENTS

REGISTRATION IN MALAYSIAREGISTRATION IN MALAYSIA

16 JUN 2011JEEVANRAJ RAJAGOPAL

Biro Pengawalan Farmaseutikal Kebangsaan

Kementerian Kesihatan Malaysia

Tel:03-78835530 Email:jeeven@bpfk.gov.my

Con

tents

� BPFK Introduction

� Definition

� Health Supplement Registration Criteria Registration Criteria

� Food/Drug Interface

� Conclusion

ORGANISATION CHART MINISTRY OF HEALTH MALAYSIAORGANISATION CHART MINISTRY OF HEALTH MALAYSIA

MINISTERPARLIMENTARY 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

ResourcesEpidemiology

Disease Control

Pharmaceutical

Care ManagementMedical

DevelopmentPlanning &

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

PracticeFamily

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

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

CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL 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

CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL OF DRUG AND COSMETICS CONTROL 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,

andandandandandandandandthe person holds the appropriate license required & issued under the CDCR

Registration and Licensing Activityand Licensing Activityunder 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 the The NPCB acts as the The NPCB acts as the The NPCB acts as the SecretariatSecretariatSecretariatSecretariat to the DCAto the DCAto the DCAto the DCA

RegistrationRegistrationRegistrationRegistration

PharmacovigilancePharmacovigilancePharmacovigilancePharmacovigilance

TrainingTrainingTrainingTraining

MAIN FUNCTIONSMAIN FUNCTIONS

SurveillanceSurveillanceSurveillanceSurveillance

AnalysisAnalysisAnalysisAnalysis

LicensingLicensingLicensingLicensing

PRODUCT REGISTRATIONREGISTRATION

OBJECTIVE OF REGISTRATION

�To ensure that all pharmaceutical product which is registered under DCA is evaluated on the on the

� safety,

�quality and

� efficacy

Product RegistrationProduct Registration

Fasa 1 Fasa 2 Fasa 3 Fasa 4 Fasa 5

Bioteknologi

Produk Veterinari

Produk Baru

Registration

1988(OTC)

RegistrationJan 1992

(TraditionalMedicine)

RegistrationFeb 2002

(Cosmetics)Notification: 1

January 2010

Registration August 2007 (Veterinary)

RegistrationAug 1985

(PrescriptionDrugs)

LicensingMay 1987

Licensing1992

Licensing

Manufacturers

Importers

Jan 1999

LicensingJan 2004

Licensing

LicensingWholesalers

July 2002Surveillance

1999

Surveillance2004

Surveillance

Bahan Aktif

Farmaseutikal

Surveillance1995

Surveillance1995

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

Registration criteria

- Applicant must be a locally incorporated company,

- and be authorized in writing by the product owner to be the holder of the product owner to be the holder of the registration certificate and be responsible for all matters pertaining to the registration of the product

Product Registration

REGISTRATION APPLICATION

On-line Quest 3 System

Registration procedure- onlinewww.bpfk.gov.my

Registration procedure- online www.bpfk.gov.my

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

REGISTRATION PROCESS

Meeting Drug Control Authority

Meeting ‘Jawatankuasa KerjaPendaftaran’

Issue registration certificate

*

Complete

Approve

Letter of rejection to applicant

Reject

REGISTRATION PROCESS

FLOW CHART

• Pharmacetical

Safety, Quality, Efficacious

Registration Criteria

• Health Supplement/

Traditional

Safety and Quality

• Cosmetics

Safety and Quality

Products Particulars Product Formula

Registration Criteria

Product Name

Product Description

Dosage Form

Dosage

-Active

ingredient

-Ban item

Labelling Requirement Packing Particulars

ManufacturerName and address

-CPP

_GMP

-CFS

-Compulsory

labelling

requirement

-Additional

Warning/

Precaution

Dosage

-Pack size

-Type of

container

-Ban item

-Excipient

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

Health Supplement

Registration

22

Product to be registered under

Health SupplementThe dietary ingredients in these

products may include: �Vitamins, Minerals, Amino

Acids�Natural substances of

plant/animal origin plant/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)

)

� 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 jelly� 6. 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

HEALTH SUPPLEMENTS

REGISTRATION CRITERIA

SAFETYUpper 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

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) 300mg5. Vitamin B2 (Riboflavine) 30mg6. Vitamin B5 (Pantothenic acid) 200mg7. Vitamin B6 (Pyridoxine) 100mg8. Vitamin B12 (Cyanocobalamin) 150mcg9. Vitamin C (Ascorbic Acid) 1000mg10. Folic acid 15mg 15mg10. Folic acid 15mg 15mg11. Niacin (Nicotinic Acid) 500mg12. Niacinamide (Nicotinamide) 250mg13. Biotin 40mg14. Calcium 1400mg15. Copper 2mg16. Iodine 300mcg17. Iron 20mg*18. Magnesium 400mg19. Manganese 5mg 20. Phosphorus 1400mg20. Selenium 300mcg21. 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)

Supportive documents:

-GRAS status (USFDA)

-Status at other reference countries like

health canada, therapeutics goods health canada, therapeutics goods

administration (TGA)

-Standard reference on the indication and

-Safety use as a health supplement product

-Journals

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 FAECIUMoENTEROCOCCUS FAECALIS

(Potential pathogenic bacterium, inadequate evidence of safety to justify their use as probiotic)

(Appendix 6 Drug Registration Guidance Document)

Non permitted/ banned ingredients

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)

Warning labels (refer appendix 2

DRGD)

Bee Pollen/Propolis

Ginseng

AlfalfaAlfalfa

Aspartame

Arginine

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 establisheddo not exceed the stated dose

safety on long term use has not been established

ASPARTAME

Unsuitable for phenylketonurics

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 individualsAsthma and allergy sufferers may be at the greater risks

(Appendix 3 Drug Registration Guidance Document)

INGREDIENTS DERIVED FROM SEAFOOD

Additional data required:

-Dioxin level certificate/ results analysis

(finished product/ raw active ingredient)

-The certificate must have specification and results

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

LABELING REQUIREMENTS

Non Permissible Name

HEALTH SUPPLEMENTS

REGISTRATION CRITERIAQUALITY

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

HEALTH SUPPLEMENTS

REGISTRATION CRITERIAQUALITYShould 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)

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

Lab Result- example-

HEALTH SUPPLEMENTS

REGISTRATION CRITERIAQUALITYIndication: - 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 productRefer to Appendix 9 DRGD

Functional Claims

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.

‘Food –Drug

Interface’

47

Food? Drug?

Classification Guideline

Product

“Food-Drug Interface”

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 ”

Guide to Classification of Food-Drug Interface Products

(Guide to determining if a product is to be regulated by the NPCB/FSQD)

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

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

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.

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

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.

Reasons for product to be rejected

�Incomplete Document

�Contains banned ingredients�Contains banned ingredients

�Does not comply to GMP

�Inappropriate GMP authority

REFERENCESRefe

rence

sRefe

rence

s

REFERENCES

Registered Product

59

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 years� Registered 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.

SUMMARY

61

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

- Pharmaceutical Services Division :

www.pharmacy.gov.my

- National Pharmaceutical Control Bureau :

63

- National Pharmaceutical Control Bureau :

www.bpfk.gov.my