Guide to Registration of Food-Drug Interface Products National

Guide to Registration of Food-Drug Interface Products  National

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 follows :

as 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 >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 ALIRAN PROSEDUR ON-LINE CARTA ALIRAN PROSEDUR ONLINE Pemohon PPP Perolehi Smart Card

Input data dan submit PKK 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 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 Peoples 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 PACKAGE LABEL 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 to 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 Johns 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 to 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

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