“ guide to registration of food-drug interface products ”

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

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• 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

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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)

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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

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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).

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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

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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).

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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