Transcript Slide 1

“Guide to Registration of
Food-Drug Interface Products ”
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
WHO Collaborating Centre
For Regulatory Control of
Pharmaceuticals
Tarikh : 4 MARCH 2009
Member of Pharmaceutical
Inspection Cooperation Scheme
KOK CHUAN FUNG
Biro Pengawalan Farmaseutikal Kebangsaan
Kementerian Kesihatan Malaysia
Jalan Universiti
46730 Petaling Jaya
MALAYSIA
Tel : 603-78835400 ext 5524 Fax : 603-79581312
Website : www.bpfk.gov.my
New Organization Structure
MS ISO 9001:2000 Certified
1
BIRO PENGAWALAN FARMASEUTIKAL
KEBANGSAAN
JalanUniversiti,
Peti Surat 319,
46730 Petaling Jaya, Selangor
Tel : 03-78835400
Fax : 03-7956 2924/ 7958 1312
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 Ali
If 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 Ali
If 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.
PRODUK TRADISIONAL
FOOD
SOURCE
Pengkelasan
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)
Vitamin
amino acid
Fatty acid
Fibre
Lyophilized Bacteria
Enzyme
mineral
Natural product that are not
traditionally used as food and of
medicinal value
Alfalfa
Spirulina
Royal Jelly
•Tongkat Ali
Manja Harum
NPCB-National Pharmaceutical Control Bureau
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.
Food base
80% or more
Food base
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
BPFK
• >80% - food base
ingredient
• <80% - food base
ingredient
• <20% - lain-lain
ingredients seperti
vitamin, mineral dan
sebagainya
• > 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 ALIRAN
PROSEDUR ON-LINE
CARTA ALIRAN PROSEDUR ONLINE
Pemohon
PPP
Perolehi Smart Card
PKK
Input data dan ‘ submit’
PKP
PPPP
BPFK menilai permohonan
Minta data tambahan
Laporan Penilaian
JKPP
Koordinasi Regulatori
Minta data tambahan
PBKD
PELESENAN
Keputusan
PBKD
SIJIL
PENDAFTARAN
PRODUK
DIKELUARKAN
APB
Produk didaftarkan
Permohonan Lesen
Kelulusan
PBKD
Senarai Produk
Pengilang
Pemborong
Lesen 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
KRITERIA PENILAIAN
Product Formula
Products Particulars
Product Name
Product Description
-Active
ingredient
-Ban item
-Excipient
Manufacturer
-Compulsory
labelling
requirement
-Additional
Warning/
Precaution
-CPP
_GMP
-CFS
-Pack size
-Type of
container
Labelling
Requirement
Packing Particulars
KRITERIA PENDAFTARAN
Keselamatan
•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
Arsenic
Lead
Cadmium
-
not more than 0.5 ppm
not more than 5.0 ppm
not more than 10 ppm
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))
PRODUCT NAME
The name of a product should not indicate :
Effectiveness , superior quality or hyperbole
Eg: 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
• 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
INDICATION
Traditionally used reducing body weight
Radix Rhizoma Rhei
Cassia Augustifolia
Garcinia cambogia
Garcinia atroviridis
Traditionally used for liver tonic
Taraxacum Officinale (Dandelion)
Silybum Marianum (Milk Thistle)
REFERENCES
Compendium Medicinal Plants
Used In Malaysia (Vol I & II)
Indeks Tumbuhan Ubat Malaysia
Chinese – English manual Of
Common- Used In Traditional
Chinese Medicine
PDR For Herbal Medicine
Indian Materia Medica (Vol 1 & II)
Pharmacopoiea Of The People’s
Republic of China
The Coloured Atlas of Chinese
Materia Medica Specified In
Chinese Pharmacopoeia
Encyclopedia Of Homeopathic
Pharmacopeia (Vol I. II & III)
LABELLING
REQUIREMENT
ITEMS
IMMED
IATE
LABEL
OUTER
LABEL
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




LABELLING
REQUIREMENT
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 label
a.Ginseng
b.Bee pollen
c.Senna leaf (Cassia) and
Rhubarb/ radix or Rhizoma
Rhei
Contraindication/Precaution
(If any )

Packaging size





ADDITIONAL STATEMENT
TO BE PRINTED
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 t
be stated:
This product contains alcohol
For products containing animal part(s), please add this
statement:
This product contains animal part(s).
WARNING LABELS
Bee
Pollen/Propolis
Ginseng
St John’s wort
Alfalfa
Camphor
Senna Leaf
Black Cohosh
WARNINGS/
PRECAUTIONS
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.
•
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
ADDITIONAL STATEMENT
TO BE PRINTED
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 t
be stated:
This product contains alcohol
For products containing animal part(s), please add this
statement:
This product contains animal part(s).
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 KASIH