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HEALTH SUPPLEMENTS
REGISTRATION IN MALAYSIAREGISTRATION IN MALAYSIA
16 JUN 2011
JEEVANRAJ RAJAGOPAL
Biro Pengawalan Farmas...
Contents
BPFK Introduction
Definition
Health Supplement
Registration CriteriaRegistration Criteria
Food/Drug Interface
Con...
ORGANISATION CHART MINISTRY OF HEALTH MALAYSIAORGANISATION CHART MINISTRY OF HEALTH MALAYSIA
MINISTER
PARLIMENTARY SECRETA...
Where are we
located?
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Jalan Universiti, P.O.Box 319,
46...
CONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTRO...
CONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTROL OF DRUG AND COSMETICSCONTRO...
Registration and Licensing Activityand Licensing Activity
under theunder the Drug Control Authority (DCA)Drug Control Auth...
RegistrationRegistrationRegistrationRegistration
PharmacovigilancePharmacovigilancePharmacovigilancePharmacovigilance
Trai...
PRODUCT
REGISTRATIONREGISTRATION
OBJECTIVE OF REGISTRATION
To ensure that all
pharmaceutical product
which is registered
under DCA is evaluated
on theon th...
Product RegistrationProduct Registration
Fasa 1 Fasa 2 Fasa 3 Fasa 4 Fasa 5
Bioteknologi
Produk Veterinari
Produk Baru
Reg...
Registration Fees
. Product Classification Processing
Fees (RM)
Analysis fees
(RM)
Total Fees
(RM)
1. Health Supplement 10...
Registration criteria
- Applicant must be a locally
incorporated company,
- and be authorized in writing by the
product ow...
Product Registration
REGISTRATION APPLICATION
On-line Quest 3 System
Registration procedure- online
www.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 ...
• Pharmacetical
Safety, Quality, Efficacious
Registration Criteria
• Health Supplement/
Traditional
Safety and Quality
• C...
Products Particulars Product Formula
Registration Criteria
Product Name
Product Description
Dosage Form
Dosage
-Active
ing...
Health Supplement Definition
Health Supplements shall
means product that are
intended to supplement
the diet taken by mout...
Health Supplement
Registration
22
Product to be registered under
Health Supplement
The dietary ingredients in these
products may include:
Vitamins, Minerals...
)
List B: List of Active ingredients that are allowed
to be combined with active
ingredients in List A
1. Acerola
2. Aloe ve...
HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
SAFETY
Upper daily limits set for some vitamins and
minerals (Appendix 9 in Drug ...
UPPER DAILY LIMITS OF VITAMINS AND MINERALS
FOR ADULTS ALLOWED IN DIETARY SUPPLEMENTS
1. Vitamin A 5000 IU
2. Vitamin D 40...
Supportive documents:
-GRAS status (USFDA)
-Status at other reference countries like
health canada, therapeutics goodsheal...
Non permitted/ banned ingredients
•Vitamin K
•Conjugated Linoleic acid (CLA)
•Glucosamine
•Boric acid/ borax
•Banned probi...
Non permitted/ banned ingredients
Those combinations are not allowed
to be registered.
Combination of Vitamin(s) with other drugs
•Vitamin (s) + Appetite Su...
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 a...
PRODUCT INFORMATION:
Warnings/precautions/drug interactions/adverse
effectsALFALFA (MEDICAGO SATIVA)
This product contains...
INGREDIENTS DERIVED
FROM SEAFOOD
Additional data required:
-Dioxin level certificate/ results analysis
(finished product/ ...
PRODUCT CONTAINING PLACENTA
Hormone test certificate:
-Must have specification of detection limit and results, mainly on e...
LABELING REQUIREMENTS
Non Permissible Name
HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Imported product:
- Certificate of Pharmaceutical Product or
- Certificat...
HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Should conform to set standards of quality:
-Product Specifications: Assa...
Specifications:
Mercury - not more than 0.5 ppm
Heavy Metal Test
Arsenic - not more than 5.0 ppm
Lead - not more than 10 p...
Lab Result
- example-
HEALTH SUPPLEMENTS
REGISTRATION CRITERIA
QUALITY
Indication:
- Allowed to be indicated as “Dietary / Food/ Health Suppleme...
Functional Claims
Pack Size
Maximum pack size allowed for tablets, pills, capsules is based on
daily dosing for a quantity not exceeding six...
‘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 “Foo...
Guide to Classification of Food-Drug Interface Products
(Guide to determining if a product is to be regulated by the NPCB/...
Produk “Food-Drug
Interface”
BKKM
• >80% - food base
ingredient
BPFK
• <80% - food base
ingredientingredient
• <20% - ingr...
Key Points For Classification
When polysaccharides (e.g ;maltodextrin) are present in capsule form,
they shall be consider...
Key Points For Classification
All protein based ingredients (e.g – casein, whey, soy protein) shall be
treated as food ing...
Key Points For Classification
Substances listed in the prohibited ingredient list of the Drug Registration
Guidance Docume...
Miscellanous
Tea Sachet
Herbal tea product in sachet form is regulated under circular of Drug
Control Authority (bil 11) i...
Reasons for product to be rejected
Incomplete Document
Contains banned ingredientsContains banned ingredients
Does not com...
REFERENCESReferencesReferences
REFERENCES
Registered Product
59
Registered Product
Registration Number: eg. MAL100604653X (with C, R, S, (E)
Product holder is allowed to do certain chang...
SUMMARY
61
Policy
-change of policy time to time
New technology/ era
-Have to be updated, eg: bilayer technology-Have to be updated, ...
- Pharmaceutical Services Division :
www.pharmacy.gov.my
- National Pharmaceutical Control Bureau :
63
- National Pharmace...
Health Supplements Registration in Malaysia
Health Supplements Registration in Malaysia
Health Supplements Registration in Malaysia
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Health Supplements Registration in Malaysia

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

Published in: Health & Medicine

Health Supplements Registration in Malaysia

  1. 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. 2. Contents BPFK Introduction Definition Health Supplement Registration CriteriaRegistration Criteria Food/Drug Interface Conclusion
  3. 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
  4. 4. 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
  5. 5. 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
  6. 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) unlessunlessunlessunless:::: the product is a registered product, andandandandandandandand the person holds the appropriate license required & issued under the CDCR
  7. 7. 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
  8. 8. RegistrationRegistrationRegistrationRegistration PharmacovigilancePharmacovigilancePharmacovigilancePharmacovigilance TrainingTrainingTrainingTraining MAIN FUNCTIONSMAIN FUNCTIONS SurveillanceSurveillanceSurveillanceSurveillance AnalysisAnalysisAnalysisAnalysis LicensingLicensingLicensingLicensing
  9. 9. PRODUCT REGISTRATIONREGISTRATION
  10. 10. OBJECTIVE OF REGISTRATION To ensure that all pharmaceutical product which is registered under DCA is evaluated on theon the safety, quality and efficacy
  11. 11. 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
  12. 12. 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
  13. 13. 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
  14. 14. Product Registration REGISTRATION APPLICATION On-line Quest 3 System
  15. 15. Registration procedure- online www.bpfk.gov.my
  16. 16. Registration procedure- online www.bpfk.gov.my
  17. 17. 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
  18. 18. • Pharmacetical Safety, Quality, Efficacious Registration Criteria • Health Supplement/ Traditional Safety and Quality • Cosmetics Safety and Quality
  19. 19. 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
  20. 20. 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
  21. 21. Health Supplement Registration 22
  22. 22. 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)
  23. 23. )
  24. 24. 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
  25. 25. 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
  26. 26. 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)
  27. 27. 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
  28. 28. 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)
  29. 29. Non permitted/ banned ingredients
  30. 30. 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)
  31. 31. Warning labels (refer appendix 2 DRGD) Bee Pollen/Propolis Ginseng AlfalfaAlfalfa Aspartame Arginine
  32. 32. 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
  33. 33. 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)
  34. 34. INGREDIENTS DERIVED FROM SEAFOOD Additional data required: -Dioxin level certificate/ results analysis (finished product/ raw active ingredient) -The certificate must have specification and results
  35. 35. 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
  36. 36. LABELING REQUIREMENTS
  37. 37. Non Permissible Name
  38. 38. 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
  39. 39. 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)
  40. 40. 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
  41. 41. Lab Result - example-
  42. 42. 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
  43. 43. Functional Claims
  44. 44. 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.
  45. 45. ‘Food –Drug Interface’ 47
  46. 46. Food? Drug? Classification Guideline Product “Food-Drug Interface”
  47. 47. 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 ”
  48. 48. Guide to Classification of Food-Drug Interface Products (Guide to determining if a product is to be regulated by the NPCB/FSQD)
  49. 49. 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
  50. 50. 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
  51. 51. 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.
  52. 52. 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
  53. 53. 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.
  54. 54. Reasons for product to be rejected Incomplete Document Contains banned ingredientsContains banned ingredients Does not comply to GMP Inappropriate GMP authority
  55. 55. REFERENCESReferencesReferences
  56. 56. REFERENCES
  57. 57. Registered Product 59
  58. 58. 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.
  59. 59. SUMMARY 61
  60. 60. 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
  61. 61. - Pharmaceutical Services Division : www.pharmacy.gov.my - National Pharmaceutical Control Bureau : 63 - National Pharmaceutical Control Bureau : www.bpfk.gov.my

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