CONTROL OF DIETARY SUPPLEMENTS IN MALAYSIA TAN LIE SIE DRUG EVALUATION AND SAFETY DIVISIONNATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA
CONTENTS Food / Drug Interface Regulatory Process in Malaysia Concerns Conclusion
FOOD/DRUG INTERFACE What is this interface? - interaction of 2 regulatory regimes; - no internationally standardised approach; - complex, with public health and safety implications
Guide to Classification of Food-Drug Interface Products (Guide to determining if a product is to be regulated by the NPCB/FQC) Product Ingredients Pure Form of active Natural product that are not Food base ingredient (singly or in traditionally used as food and of combination) medicinal value ♦ Vitamin • Alfalfa tablets ♦ mineral • Spirulina ♦ amino acid • Royal Jelly If a product contains less than 80% If a product contains 80% or ♦ Fatty acid • Noni Juice of food ingredients, and more than more of food ingredients, singly ♦ Fibre 20% active ingredients, such or in combination, and with equal ♦ LyophilizedBacteria • Pegaga tablet ♦ Enzyme • Herbal product products should be regulated by to or less than 20% biologically NPCB. Not withstanding this general active ingredients of natural rule, for products containing specific products with pharmacological ingredients which possess high and / or therapeutic properties, potencies, even if they contain less the product has to be regulated than 20% of the active ingredients, by BKMM they shall be reviewed by the NPCB-National Pharmaceutical Control Bureau Committee and may be regulated by BPFK if it is found appropriate FQC – Food Quality Control 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.
FOOD/DRUG INTERFACE If a product contains less than 80% of food ingredients, and more than 20% active ingredients, such products should be regulated by NPCB. Not withstanding this general rule, for products containing specific ingredients which possess high potencies, even if they contain less than 20% of the active ingredients, they shall be reviewed by the Committee and may be regulated by BPFK if it is found appropriate
FOOD/DRUG INTERFACE 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 BKMM.
FOOD/DRUG INTERFACEFollowing criteria should not be used assole criteria for classification but can beused as a guide Intended use and claim Instruction for use and pharmaceutical dosage forms like tablet, capsule, etc
DRUG CONTROL AUTHORITYNATIONAL PHARMACEUTICAL CONTROL BUREAU (NPCB) (as Secretariat / Executive Arm)
DRUG CONTROL AUTHORITY (DCA) Register all drugs (prescription, over-the- counter and herbal medicines) and cosmetic products License manufacturers, importers and wholesalers of registered products Monitor the quality and safety of marketed products through Post-Registration Market Surveillance & Adverse Drug Reactions Reporting
The Control of Drugs and Cosmetics Regulations 1984Regulation 7(1)(a) requires ALL products to beregistered with the DCA prior to beingimported, manufactured, sold or supplied,unless the product is exempted under specificprovisions of these Regulations.
The Control of Drugs and Cosmetics Regulations 1984A product as defined in the Regulations,means a drug in a pharmaceutical dosageform, or a cosmetic, having a singularidentity, composition, characteristics andorigin .
The Control of Drugs andCosmetics Regulations 1984A drug is used on humans (and animals) to prevent, cure, treat, or reduce illness , to diagnose disease, for contraception, to induce anaesthesia (sedate), to change or to control physiological function, to control body weight, general maintenance or promotion of health or well being
DIETARY SUPPLEMENTS Products intended to supplement the diet, taken by mouth in forms such as pills, capsules, tablets, liquids or powders and not represented as conventional food. May include ingredients such as Vitamins, Minerals, Amino Acids, Natural Substances of plant/animal origin, Enzymes Substances with nutritional / physiological function
Why register dietary supplements?Need to protect consumer interests* Record of products registered and their respective responsible market authoriztion holders and manufacturers* Monitoring and enforcement* Regulate claims* Safety aspects
REGISTRATION CRITERIA SAFETY Products will not be registered if there are public health concerns based on safety considerations (ingredients used, combinations) Upper daily limits set for some vitamins and minerals Warnings/precautions may be required in product labelling
REGISTRATION CRITERIA QUALITY Have to comply with current Good Manufacturing Practices (cGMP) requirements - infrastructure /facilities - personnel - processes and controls Should conform to set standards of quality - raw materials - finished product - stability testing
REGISTRATION CRITERIA CLAIMS ( EFFICACY ) Supplements may not bear disease claims (ie capable of curing, treating or preventing disease); either explicit or implied Allowed to be indicated as Dietary / Food/ Nutritional Supplement Function claims which describe the physiological role of the nutrient in normal functioning of the body may be permitted
REGISTRATION PROCESS On-line registration process (single stage) Implementation of the on-line registration system : 1 July 2003 - for pharmaceuticals (generics), and the OTC products 1 January 2004 - for traditional products 1 Mac 2004 - targeted date for the NCE and Biotech products
Flow Chart of Registration Process(Pre-market Approval) Applicant Obtain smart card Legal Requirements Input data & submit Guidelines, Criteria, Process (abridged) BPFK evaluate application Quality test for Not satisfactory Request for additional info traditional productsSatisfactory Prepare evaluation report Report Request for JKPP incomplete additional Report info complete Secretariat DCA
REGISTRATION PROCESS Unique registration no MAL20001198X Registration for a maximum period of 5 years Updating of product information Re-register before expiry of term to be maintained on product register
CONCERNS Consumer perception that a product in the form of a medicine is perceived to be a drug for treatment Responsible information provision. There is potential high risk to consumers as a result of insufficient or incorrect information, or fraudulent products. - Although a product may not be toxic or dangerous, consumers may compromise their health by not seeking proper medical attention. - Claims about supplements should not divert attention away from eating a healthy diet
CONCLUSION There is tremendous interest in anddemand for health supplements and a need for regulators to accommodate both the industry and consumers in this area.
CONCLUSION However the growing market for supplements in a less restrictive regulatory environment creates thepotential for supplements to be prone to quality-control problems
CONCLUSION Authority to regulate and approve product registration and licensingthrough pre-market assessment helps ensure that consumers have access to safe, high quality, properly labeled products.