registration in malaysia - Kementerian Kesihatan Malaysia

BPFK Introduction Definition Health SupplementRegistration Criteria Food/Drug Interface ConclusionContents

Where are welocated?National Pharmaceutical Control BureauMinistry of Health MalaysiaJalan Universiti, P.O.Box 319,46730 Petaling Jaya, SelangorMalaysiaTel : 603-7957 3611Fax: 603-7956 2924/ 7958 1312

CONTROL OF DRUG AND COSMETICSACT 1984 (REVISED 2006)Sub Regulation 7(1)No person shall-manufacture-sell-supply-import-possess-or administer any product

CONTROL OF DRUG AND COSMETICSACT 1984 (REVISED 2006)unless:the product is a registered product,andthe person holds the appropriate licenserequired & issued under the CDCR

MALAYSIARegistration and Licensing Activityunder the Drug Control Authority (DCA))The NPCB acts as the Secretariat to the DCA

PRODUCTREGISTRATION

OBJECTIVE OF REGISTRATION To ensure that allpharmaceutical productwhich is registeredunder DCA is evaluatedon the safety, quality and efficacy

Product RegistrationProduk BaruFasa 1 Fasa 2 Fasa 3 Fasa 4 Fasa 5BioteknologiRegistrationAug 1985(PrescriptionDrugs)Registration1988(OTC)RegistrationJan 1992(TraditionalMedicine)RegistrationFeb 2002(Cosmetics)Notification: 1January 2010RegistrationAugust 2007(Veterinary)Produk VeterinariLicensingMay 1987Licensing1992LicensingManufacturersImportersJan 1999LicensingJan 2004LicensingBahan AktifFarmaseutikalSurveillance1995Surveillance1995LicensingWholesalersJuly 2002Surveillance1999Surveillance2004Surveillance

Registration Fees. Product Classification ProcessingFees (RM)Analysis fees(RM)Total Fees(RM)1. Health Supplement 1000.00 Single activeingredient:1,200.00Two or moreactiveingredients :2,000.002,200.003,000.002. For Export Only HealthSupplement1,000.00 1,000.00

Registration criteria- Applicant must be a locallyincorporated company,- and be authorized in writing by theproduct owner to be the holder of theregistration certificate and beresponsible for all matters pertainingto the registration of the product

Product RegistrationREGISTRATION APPLICATIONOn-line Quest 3 System

Registration procedure- onlinewww.bpfk.gov.my

Registration procedure- onlinewww.bpfk.gov.my

Screening by Head of HealthSuplemen Unit (KPP)Applicant reply to KPP regardingIncomplete documentationCompleteREGISTRATION PROCESSFLOW CHARTPayment will be asked to be doneFurther evaluation by HealthSupplement OfficerCompleteMeeting ‘Jawatankuasa KerjaPendaftaran’Meeting Drug ControlAuthorityApproveRejectIncompleteReply Through Quest 3to comply to ourrequirementsLetter ofrejection toapplicant*ApplicantIssue registration certificate

• PharmaceticalRegistration CriteriaSafety, Quality, Efficacious• Health Supplement/TraditionalSafety and Quality• CosmeticsSafety and Quality

Registration CriteriaProducts ParticularsProduct FormulaProduct NameProduct DescriptionDosage FormDosage-Activeingredient-Ban item-Excipient-Compulsorylabellingrequirement-AdditionalWarning/PrecautionLabelling RequirementManufacturerName and address-CPP_GMP-CFSPacking Particulars-Pack size-Type ofcontainer

Health Supplement DefinitionHealth Supplements shallmeans product that areintended to supplementthe diet taken by mouth informs such as pills,capsules, tablets, liquidsor powders and notrepresented as aconventional food or as asole item of a meal or thediet

Health SupplementRegistration22

Product to be registered underHealth SupplementThe dietary ingredients in theseproducts may include:Vitamins, Minerals, AminoAcidsNatural substances ofplant/animal originEnzymes, substances withnutritional /physiologicalfunctionand/orCombination with selected traditionalsubstance:(eg: Bee Pollen, Blue Algae,Chlorella, Chlorophyll, Alfafa,Spirulina, Garlic)

List B: List of Active ingredients that are allowedto be combined with activeingredients in List A1. Acerola2. Aloe vera3. Allium sativum (Garlic)4. Bee pollen5. Bee propolis6. Borago officinalis (Borage oil)7. Chlorella (Chlorella pyrenoidosa,Chlorella sorokianiana, Chlorellavulgaris)8. Chlorophyll9. Camellia sinensis10. Evening primrose oil/Oenotherabiennis11. Ganoderma12. Ginseng/ Panax ginseng16. Medicago sativa (Alfafa)17. Pine bark (pycnogenol)/ Pinus miritus(pinus massoniana, pinus pinaster18. Pine pollen19. Propolis20. Rosa canina21. Rose hips22. Rosmarinus officinalis23. Royal jelly24. Seaweed25. Shark cartilage26. Shark liver oil27. Spirulina (Spirulina platensis)28. Tagetes erecta (Marigold)29. Vitis vinisfera (Grape seed extract)30. Wheat Germ Oil31. Wheat grass13. Hordeum Vulgare (Barley)14. Kelp/ Laminaria sp.15. Linum usitatissimum (Flaxseed oil)

HEALTH SUPPLEMENTSREGISTRATION CRITERIASAFETYUpper daily limits set for some vitamins andminerals (Appendix 9 in Drug RegistrationGuidance Document)New active ingredients / new doseNew combinationNon permitted/ banned ingredientsProduct InformationWarnings/precautions/drug interactions/adverseeffects

UPPER DAILY LIMITS OF VITAMINS AND MINERALSFOR ADULTS ALLOWED IN DIETARY SUPPLEMENTS1. Vitamin A 5000 IU2. Vitamin D 400 IU3. Vitamin E 400 IU4. 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 15mg11. Niacin (Nicotinic Acid) 500mg12. Niacinamide (Nicotinamide) 250mg13. Biotin 40mg14. Calcium 1400mg15. Copper 2mg16. Iodine 300mcg17. Iron 20mg*18. Magnesium 400mg19. Manganese 5mg20. Phosphorus 1400mg20. Selenium 300mcg21. Zinc 25mg(Note: * For pre and antenatal use, as part of a multivitamin and mineralpreparation, levels higher than the 20mg limit established for adults may bepermitted at the discretion of the DCA)

Supportive documents:-GRAS status (USFDA)-Status at other reference countries likehealth canada, therapeutics goodsadministration (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)oENTEROCOCCUS FAECIUMoENTEROCOCCUS FAECALIS(Potential pathogenic bacterium, inadequate evidence of safety tojustify their use as probiotic)(Appendix 6 Drug Registration Guidance Document)

Non permitted/ banned ingredients

Warning labels (refer appendix 2DRGD)Bee Pollen/PropolisGinsengAlfalfaAspartameArginine

Compulsory:Warning labels (refer appendix 2 DRGD)L-ARGININEArginine is not recommended for patients following a heart attack‘CHITOSAN, CHONDROITIN, FISH OILDerived from seafoodGINSENGsafe use of ginseng in pregnant women and children has not been establisheddo not exceed the stated dosesafety on long term use has not been establishedASPARTAMEUnsuitable for phenylketonurics

PRODUCT INFORMATION:Warnings/precautions/drug interactions/adverseeffectsALFALFA (MEDICAGO SATIVA)This product contains Alfalfa (Medicago sativa).Individuals with a predisposition to systemic lupus erythematosus should consult theirphysician before consuming this productBEE POLLENThis product contains Bee Pollen and may cause severe allergic reactions, includingfatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at greater risksROYAL JELLYThis product contains royal jelly and may cause severe allergic reactions includingfatal anaphylactic reactions in susceptible individualsAsthma and allergy sufferers may be at the greater risks(Appendix 3 Drug Registration Guidance Document)

INGREDIENTS DERIVEDFROM SEAFOODAdditional data required:-Dioxin level certificate/ results analysis(finished product/ raw active ingredient)-The certificate must have specification and results

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

LABELING REQUIREMENTS

Non Permissible Name

QUALITYHEALTH SUPPLEMENTSREGISTRATION CRITERIAImported product:- Certificate of Pharmaceutical Product or- Certificate of Free Sale- GMP Certificate: Have to comply with current GoodManufacturing Practices (GMP) requirements(infrastructure /facilities, personnel, processes andcontrols)Local product:- Manufacturer’s Licence

HEALTH SUPPLEMENTSREGISTRATION CRITERIAQUALITYShould conform to set standards of quality:-Product Specifications: Assay-Raw materials (CoA)-Finished Product Quality Control (FPQC)-Stability Data-Heavy metals : Pb, Hg, As, Cd-Microbial Limit Test: bacteria, fungi, specifiedmicroorganism-Disintegration test, Weight of Uniformity Test-Manufacturing process-In-process Quality Control (IPQC)

Specifications:Heavy Metal TestMercury - not more than 0.5 ppmArsenic - not more than 5.0 ppmLead - not more than 10 ppmCadmium -not more than 0.3 ppm

Lab Result- example-

HEALTH SUPPLEMENTSREGISTRATION CRITERIAQUALITYIndication:- Allowed to be indicated as “Dietary / Food/ Health Supplement”.Claims:-Supplements may not bear disease claims (ie capable of curing, treatingor preventing disease); either explicit or implied.-Functional claims which describe the physiological role of the nutrient innormal functioning of the body may be permitted-Claim for active ingredients and not for productRefer to Appendix 9 DRGD

Functional Claims

Pack SizeMaximum pack size allowed for tablets, pills, capsules is based ondaily dosing for a quantity not exceeding six (6) months usage.Shape of tabletAnimal shapes tablet are not allowed.Sustained release and Timed release dosage formProtocol of analysis, In- Process Quality Control (IPQC), FinishedProduct Specification (FPQC) and Certificate of Analysis (COA)should be submitted.

‘Food –DrugInterface’47

Classification GuidelineFood?Drug?Product“Food-Drug Interface”

Product “Food-DrugInterface”Classifications of Product is through “Food-Drug Interface”by : Food-Drug Interface classification committee- National Pharmaceutical Control Bureau, NPCB- Food Safety and Quality Division, FSQDMinistry Health of MalaysiaAppendix 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-DrugInterface”BKKM• >80% - food baseingredientBPFK•

Key Points For ClassificationWhen polysaccharides (e.g ;maltodextrin) are present in capsule form,they shall be considered as excipient and shall not be included indetermining the percentage of active ingredientPermitted probiotics when present by itself singly or in combination incapsule or tablet form shall be regulated under BPFK and shall containminimum 10 6 viable cells/g of the viable cells for each strain.Permitted probiotics when present in foods shall be treated as foodingredients and shall contain minimum 10 6 viable cells/g of the viablecells for each strain.Product Classification Form : BPFK-003

Key Points For ClassificationAll protein based ingredients (e.g – casein, whey, soy protein) shall betreated as food ingredients even though they are present inpharmaceutical dosage form.Any foods or combination of foods may be regulated under BKKM eventhough they are present in capsule, softgel, tablet or sachet is to bedecided together with the intended use.Capsules containing one or more natural ingredients that are nottraditionally used as food shall be regulated under BPFKOils that are not traditionally used as food or combination e.g eveningprimrose oil, garlic oil, fish oil, flaxseed oil and grapeseed oil in capsuleor softgel shall be regulated under BPFK.

Key Points For Classification Substances listed in the prohibited ingredient list of the Drug RegistrationGuidance Document (DRGD) shall not be permitted for used in anyproducts. 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)-Psyllium Husk (>3.5g/day under BPFK)-Schedule Poisons (BPFK)-Probiotics more than 10 6 viable cell/gBorang pengkelasan produk: BPFK-003

MiscellanousTea SachetHerbal tea product in sachet form is regulated under circular of DrugControl Authority (bil 11) in bpfk/02/5/1.3 in which herbal tea in sachetthat has medical claim only will be controlled and need to be registeredwith Drug Control Authority (DCA).LozengesThe industrial company is not allowed to put the word ’lozenges’ on foodproduct.Borang pengkelasan produk: BPFK-003

Reasons for product to be rejectedIncomplete DocumentContains banned ingredientsDoes not comply to GMPInappropriate GMP authority

REFERENCESReferences

REFERENCES

Registered Product59

Registered ProductRegistration Number: eg. MAL100604653X (with C, R, S, (E)Product holder is allowed to do certain changes on the registeredproduct through ‘variation’ through online.Registered product will be check through surveilansRegistered product validity: 5 yearsReregistration need to be done every 5 years, to ensure the registeredstatus. Six months before the validity of registration expires need to besubmitted.

SUMMARY61

Policy-change of policy time to timeNew technology/ era-Have to be updated, eg: bilayer technologyNew invention by applicant-New dosage form, extended release/slowrelease, increased standards-Client charter on time to register ,eg: singleingredient 60 working days, combinationingredient 90 working days

- Pharmaceutical Services Division :www.pharmacy.gov.my- National Pharmaceutical Control Bureau :www.bpfk.gov.my63

registration in malaysia - Kementerian Kesihatan Malaysia

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