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New Organization Structure 1
“Guide to Registration of Food-Drug Interface Products ”
Tarikh : 4 MARCH 2009
KOK CHUAN FUNGBiro Pengawalan Farmaseutikal KebangsaanKementerian Kesihatan MalaysiaJalan Universiti46730 Petaling JayaMALAYSIATel : 603-78835400 ext 5524 Fax : 603-79581312 Website : www.bpfk.gov.my
WHO Collaborating Centre For Regulatory Control of Pharmaceuticals
Member of Pharmaceutical Inspection Cooperation Scheme
MS ISO 9001:2000 Certified
National Pharmaceutical Control BureauMinistry of Health Malaysia
JalanUniversiti, Peti Surat 319,
46730 Petaling Jaya, Selangor Tel : 03-78835400
Fax : 03-7956 2924/ 7958 1312
BIRO PENGAWALAN FARMASEUTIKAL
KEBANGSAAN
Introduction
• Malaysians are now more health conscious and there is generally greater awareness of the importance of nutrition to overall well-being.
• In recent years, many consumers also rely on a variety of “dietary supplements” to improve their health.
• These supplements (sometimes referred to as “health food/beverage”) comprise a diverse group of products that are now freely available through a myriad of outlets.
Introduction
• A variety of products are available in the market, supposedly for the prevention and even treatment of the chronic diseases.
• These products may range from foods modified to have special properties or pure forms of vitamins and minerals and extracts of various botanical or animal products.
• These products are marketed through a variety of channels and often carry a variety of functional and health claims.
• It is important to monitor and regulate the marketing and sale of these products so as to protect the interest of consumers.
Introduction
• There are, however, various products in the market that were not clearly marketed as “food” or “drugs”.
• These have been termed as “food-drug interphase products” and include a variety of so called health products.
• Previously, it has been difficult to determine which authority should regulate the marketing and sale of such products, ie BKMM or BPFK. This has caused difficulty to the companies intending to market such products. It is also not beneficial to the consumer as the products could be in the market and not regulated by either of the authorities.
Introduction
• To overcome these problems and to enable a quick decision to be made as to which authority should regulate a particular product, a committee called Committee for the Classification of Food-Drug Interphase Products (Jawatankuasa Pengkelasan Keluaran Food-Drug Interphase) has been formed since year 2000.
• The main terms of reference of the committee is to assist the BKMM and BPFK in classifying an application from the industry which is not clearly a food or drug (a food-drug interphase (FDI) product) in a consistent manner.
• Other duties include advising the two divisions of the Ministry of Health in strengthening and updating the relevant regulations as well as to provide scientific input on these products.
Classification of FDI
• Through a series of meetings of the Committee for the Classification of Food-Drug Interphase Products, the Divisions of Food Quality Control (BKMM) and the National Pharmaceutical Control Bureau (BPFK) have arrived at a system for the classification of food-drug interphase products.
• This classification is based on multiple criteria system as follows :
Classification of FDI
1. If a product contains 80% or more of food ingredients, singly or in combination, and with equal to or less than 20% of biologically active ingredients of natural products with pharmacological and/or therapeutic properties, the product has to be regulated by BKMM.
Example
• Beverage containing Tongkat AliIf the beverage contains 85% of
food/drinks ingredient (e.g.fruit juice) and 15% of Tongkat Ali ingredient.
The product is regulated by BKMM
Classification of FDI
2. If a product contains less than 80% of food-based ingredients and more than 20% of the active ingredients, such product shall be regulated by BPFK.
Example
• Beverage containing Tongkat AliIf the beverage contains 75% of
food/drinks ingredient (e.g.fruit juice) and 25% of Tongkat Ali ingredient.
The product is regulated by BPFK
Classification of FDI
3. If the product is a ‘pure’ form (close to 100%) of active ingredients, eg vitamins, minerals, amino acids, fatty acids, fibre, enzymes, etc, the product has to be regulated by BPFK.
Classification of FDI
4. Products containing solely natural ingredients that are not traditionally used as food/beverage and possess medicinal value, such as alfalfa, spirulina, royal jelly, noni juice, rooibose tea, pegaga tablet and other herbal products shall be regulated by BPFK.
Classification of FDI
• When there is greater uncertainty about the efficacy and safety of a product, BPFK would be the prefered authority to regulate it.
• This is to enable closer scrutiny of such products, to better safe guard the interest of consumers.
Other Criteria
• The following may be used as additional criteria to assist in the classification of products:
1. Intended use and claims made by the product. Eventually, if a product has been decided to be regulated by BKMM, no claims shall be made, other than those permitted by the food regulations.
Other Criteria
2. Instruction for use and pharmaceutical dosage forms such as tablet, capsule.
FOOD SOURCEPengkelasan
PRODUK TRADISIONAL
FOOD ? DRUG ?
Produk “Food-Drug Interface”
Guide to Classification of Food-Drug Interface Products(Guide to determining if a product is to be regulated by the NPCB/FSQD)
Product
Ingredients
Pure Form of active ingredient (singly or in
combination)
Natural product that are not traditionally used as food and of
medicinal value
Food base
Vitaminamino acidFatty acidFibreLyophilized BacteriaEnzymemineral
Alfalfa SpirulinaRoyal Jelly•Tongkat AliManja Harum
80% or more Food base
Less than 80% food base or more than 20% active ingredients of
natural products. But if the latter possess high potencies, the product shall be reviewed by the Committee, even if they contain less than 20% of
these ingredients.NPCB-National Pharmaceutical Control Bureau
FSQD – Food Safety and Quality Division
• If a product is more than 80% food based but contains pure forms of active ingredient (e.g.: vitamins & minerals) that exceed the amounts permitted in Food Regulations 1985, the company shall be advised to reduce the amounts of these active ingredients and be regulated by FQC.• Intended use and claim should not be used as sole criteria for classification but can be used as a guide• Instruction for use and pharmaceutical dosage form like tablet, capsule, should not be used as criteria for classification but can be used as a guide.
Produk “Food-Drug Interface”
BKKM• >80% - food base
ingredient
• <20% - lain-lain ingredients seperti vitamin, mineral dan sebagainya
BPFK• <80% - food base
ingredient
• > 20% active ingredient
PERMOHONAN PENDAFTARAN
Quest 2 on-line system(2004)
Keperluan asas untuk on-line
• INTERNET CONNECTIVITY
Subscribe internet connectivity (Jaring/TMNet),
• HARDWARE & SOFTWARE
Personal Computers, Related Softwares and auxiliary items such as printer, scanner/digital camera for imaging purposes,
• MEMBERSHIP REGISTRATION
Membership form made available on public domain of NPCB Quest2 Website,
• PURCHASE OF DIGITAL CERTIFICATE
PROSEDUR PENDAFTARAN - SECARA ONLINE
PANDUAN
DRUG REGISTRATION GUIDANCE
DOCUMENT
www.bpfk.gov.my
KOS PENILAIAN PRODUK
Bil. Jenis/Kategori Produk Bayaran pemprosesan
Kos Ujian per produk
1. Produk Tradisional RM 500 RM 700
Jumlah perlu dibayar utk 1 produk tradisional
RM 1200
CARTA ALIRANPROSEDUR ON-LINE
Pemohon
Perolehi Smart Card
Input data dan ‘ submit’
BPFK menilai permohonan
Laporan Penilaian
JKPP Minta data tambahan
Minta data tambahan
Koordinasi Regulatori PBKD
PPP
PPPP
PKP
PKK
CARTA ALIRAN PROSEDUR ONLINE
PELESENAN
Produk didaftarkan
Keputusan Keputusan PBKDPBKD
Permohonan Lesen PengilangPengilangPemborongPemborong
SIJIL SIJIL PENDAFTARAN PENDAFTARAN PRODUK PRODUK DIKELUARKANDIKELUARKAN
Senarai ProdukSenarai Produk
APBAPB
KelulusanKelulusanPBKDPBKD
Lesen dikeluarkanLesen dikeluarkan
PRODUK BERDAFTAR
No: Pendaftaran unik eg. MAL04040453T/TC/TCR/TE
Pemegang dibenarkan untuk membuat beberapa pindaan terhadap maklumat produk berdaftar melalui permohonan ‘variasi’ ( online)
Produk yang berdaftar akan disemak dari segi pematuhan terhadap syarat-syarat pendaftaran melalui aktiviti surveilans
( pemantauan)
Tempoh Pendaftaran Produk: 5 tahun
Pemberitahuan Pendaftaran Semula perlu dikemukakan untuk mengekalkan pendaftaran 6 bulan sebelum tempoh pendaftaran luput
Lesen-lesen yang berkaitan perlu diperbaharui setahun sekali
Products Particulars Product Formula
Labelling Requirement
Packing Particulars
Manufacturer-CPP
_GMP -CFS
KRITERIA PENILAIAN
-Compulsory labelling requirement -Additional Warning/Precaution
Product NameProduct Description
-Pack size-Type of container
-Active ingredient-Ban item-Excipient
Keselamatan
KRITERIA PENDAFTARAN
•Tidak mengandungi bahan yang tidak dibenarkan
( banned substances )
• Ujian makmal (Had Logam Berat, Had kontaminasi
mikrobial, bahan campur-palsu)
• Mengandungi bahan dalam kuantiti yang dibenarkan (eksipien)
• Maklumat Produk : amaran / interaksi/kesan advers ,nama
produk tidak mengelirukan
• Indikasi yang dibenarkan
UJIAN MAKMAL
Seperti:- Ujian Pengecaian - Ujian Keseragaman Berat- Ujian Had Logam Berat- Ujian Had Kontaminasi Microorganisma- Ujian Kandungan / identifikasi
dan sebagainya
Contoh :Ujian Had Logam Berat
Spesifikasi :
Mercury - not more than 0.5 ppm Arsenic - not more than 5.0
ppm Lead - not more than 10 ppm
Cadmium- not more than 0.3 ppm
LAPORAN UJIAN MAKMAL- contoh -
CONTOH SENARAI HERBA TERLARANG
(HERBA ATAU TERBITANNYA)• (i) Contoh Senarai herba yang mengandungi
Racun Berjadual seperti yg disenarai di bawah Akta Racun 1952
• Aconitum• Asidosperma quebracho• Atropa belladona• Black nightshade • Berberis• Calabar bean (physostigma venenosum)• Cabola albarrane (squill)• Chondodendron tomentosum• Colchicum autumnale
• Datura metel (Kecubung)• Datura stramonium• Digitalis purpurea folium• Drimia maritima (Squill)• Ephedra Herbs• Foxglove leaf• Gelsemium sempervirens• Hyoscyamus muticus• Hyoscyamus niger• Larrea tridenata• Larnea Mekicara• Lobelia inflata• Lobelia nicotianifolia• Mitragyna speciosa Korth. (mitragynine)/ Daun
ketum
Senarai Herba Terlarang (mengikut kesan adverse)
• Dryabalanops aromatica & Borneolum syntheticum(mengandungi camphor & borneol – tidak dibenarkan bagi persediaan oral)
• Chapparal ( Larrea tridentate & Larrea mexicana)(dilaporkan menyebabkan keracunan hati).
• Hydrastis canadensis(dilaporkan mempunyai kesan ke atas sistem saraf )
• Magnolia officinalis(dilaporkan menyebabkan keracunan ginjal (buah pinggang))
The name of a product should not indicate :
Effectiveness , superior quality or hyperboleEg: Best, Power, Hikmat, Penawar, VIP, Good, Mustajab , Superior, Fabulous, Fantastic, Superior, Extremely, Unique, Ideal etc
Prevention, diagnosis or treatment of the diseases and condition of human beings as specified in the Schedule to The Medicines (Advertisement & Sale) Act 1956 (Revised – 1983) ;
Eg : Diabetes, Asthma ,Leprosy , Cancer
Product with a name containing the term "Doctor" or "Dr.“
Eg : Dr Sunny
PR
OD
UC
T N
AM
E
• Traditionally used….……
GENERAL HEALTH MAINTENANCE - for general health maintenance / for general well being - for health and strengthening the body
• BONE, MUSCLE AND JOINT / TULANG, OTOT & SENDI - for strengthening muscle and bone - for relieving muscular ache . - for relieving waist ache and backache
BLOOD & BODY FLUID / DARAH & CECAIR BADAN - for improving blood circulation - to improve urination - for improving bowel movement
Traditionally used reducing body weight
Radix Rhizoma RheiCassia AugustifoliaGarcinia cambogiaGarcinia atroviridis
Traditionally used for liver tonicTaraxacum Officinale (Dandelion)Silybum Marianum (Milk Thistle)
IND
ICA
TIO
N
Compendium Medicinal Plants Used In Malaysia (Vol I & II)Indeks Tumbuhan Ubat Malaysia Chinese – English manual Of Common- Used In Traditional Chinese MedicinePDR For Herbal MedicineIndian Materia Medica (Vol 1 & II)Pharmacopoiea Of The People’s Republic of ChinaThe Coloured Atlas of Chinese Materia Medica Specified In Chinese PharmacopoeiaEncyclopedia Of Homeopathic Pharmacopeia (Vol I. II & III)
RE
FE
RE
NC
ES
LA
BE
LL
ING
R
EQ
UIR
EM
EN
T
ITEMS IMMEDIATE LABEL
OUTERLABEL
PACKAGE INSERT
BLISTER PACK
Product name and dosage form
Active ingredients / content and quantity (mg or g )
Name and strength/concentration of preservative (liquid preparation only)
Source of gelatin (excipient and capsule)/If from porcine source.
Indication (Use the proposed indication)
Expiry date
Batch number
Manufacturing date
LA
BE
LL
ING
R
EQ
UIR
EM
EN
T
Name and address of manufacturer
Name and address of repacker
Registration number (MAL)
Storage condition
Dosage & administration
Recommended usage
Instruction/additional statement (if any)
Parts of plant used
Alcohol content (If any)
Warning labela.Ginsengb.Bee pollenc.Senna leaf (Cassia) and Rhubarb/ radix or Rhizoma Rhei
Contraindication/Precaution (If any )
Packaging size
If symptoms persist, please consult a doctor.
This is a traditional medicine.
Keep out of reach of children & Jauhi dari kanak-kanak
For products containing porcine, please added this
statement:
This product contains animal part(s) (porcine/pig).
For products containing alcohol, this statement needs to be stated:
This product contains alcohol
For products containing animal part(s), please add this statement:
This product contains animal part(s).
AD
DIT
ION
AL
ST
AT
EM
EN
T
TO
BE
PR
INT
ED
WARNING LABELS
Bee Pollen/Propolis
Ginseng
St John’s wort
Alfalfa
Camphor
Senna Leaf
Black Cohosh
For products containing BLACK COHOSH
(CIMIFUGAE RACEMOSA) , state: • Stop taking this product if signs and symptoms
suggestive of liver injury develop such as tiredness,
loss of appetite, yellowing of the skin and
eyes or severe upper stomach pain with nausea and
vomiting or dark urine and consult your doctor
immediately.
Patients using herbal medicinal products should tell their doctor about it.•
WA
RN
ING
S/
PR
EC
AU
TIO
NS
For products containing ST. JOHN ‘S WORT (Hypericum Perforatum), state:
The product may interact with other medicines
Please consult a doctor / pharmacist before using it
For products with indication ‘To regulate menstruation / to improve menstrual flow’ state :
Contraindicated in pregnant women
For products with indication ‘To reduce body weight’ state : Balanced diet and regular exercise are essential
For products with indication ‘Anti-diarrhoea’ state:
Contraindicated in children below 1 year old
If symptoms persist, please consult a doctor.
This is a traditional medicine.
Keep out of reach of children & Jauhi dari kanak-kanak
For products containing porcine, please added this
statement:
This product contains animal part(s) (porcine/pig).
For products containing alcohol, this statement needs to be stated:
This product contains alcohol
For products containing animal part(s), please add this statement:
This product contains animal part(s).
AD
DIT
ION
AL
ST
AT
EM
EN
T
TO
BE
PR
INT
ED
KESIMPULAN
• Kualiti dan Keselamatan adalah tanggungjawab :
– Pengilang– Pemilik produk– Badan regulatori– Pengamal perubatan– Peniaga– Pengguna
LAMAN WEB UNTUK RUJUKAN LANJUT
Biro Pengawalan Farmaseutikal Kebangsaan: http://www. bpfk.gov.my
Bahagian Perkhidmatan Farmasi: http://www.pharmacy.gov.my
Malaysia Adverse Drug Advisory (MADRAC)
http://www.madrac.gov.my/madrac
TERIMA KASIHTERIMA KASIH