CONTROL OF DIETARY SUPPLEMENTS IN MALAYSIA TAN LIE SIE DRUG EVALUATION AND SAFETY DIVISION NATIONAL...
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Transcript of CONTROL OF DIETARY SUPPLEMENTS IN MALAYSIA TAN LIE SIE DRUG EVALUATION AND SAFETY DIVISION NATIONAL...
CONTROL OF DIETARY
SUPPLEMENTS IN MALAYSIA
CONTROL OF DIETARY
SUPPLEMENTS IN MALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISIONNATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA
Seminar on dietary supplements - 15 January 2004
What is this interface? - interaction of 2
regulatory regimes; - no internationally
standardised approach; - complex, with public
health and safety implications
FOOD/DRUG INTERFACE
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 ingredient (singly or in
combination)
Natural product that are not traditionally used as food and of
medicinal value
Food base
Vitaminmineralamino acidFatty acidFibreLyophilizedBacteriaEnzyme
Alfalfa tabletsSpirulinaRoyal JellyNoni JuicePegaga tabletHerbal product
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
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.
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 NPCB. Not withstanding this general rule, for 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 NPCB if it is found necessary
FOOD/DRUG INTERFACE
If a product is more than 80% food based butcontains 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 beregulated by BKMM.
FOOD/DRUG INTERFACE
Following criteria should not be used assole criteria for classification but can
be used as a guide
Intended use and claim
Instruction for use and pharmaceutical dosage forms like tablet, capsule, etc
FOOD/DRUG INTERFACE
DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICALCONTROL 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 1984
Regulation 7(1)(a) requires ALL products to be registered with the DCA prior to being imported, manufactured, sold or supplied, unless the product is exempted under specific provisions of these Regulations.
The Control of Drugs and Cosmetics Regulations 1984
A “product”as defined in the Regulations, means “a drug in a pharmaceutical dosage form, or a cosmetic, having a singularidentity, composition, characteristics and origin”.
The Control of Drugs and Cosmetics
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 1 July 2003 - for pharmaceuticals (generics), and the “OTC” products
1 January 20041 January 2004 - for traditional products
1 Mac 20041 Mac 2004 - targeted date for the NCE and Biotech products
Flow Chart of Registration Process (Pre-market Approval)
Legal Requirements Guidelines, Criteria, Process (abridged) Quality test for
traditional products
Obtain smart card
JKPP
Applicant
BPFK evaluate application
Request for additional info
Prepare evaluation report
Request for additional
info
Secretariat
Not satisfactory
Satisfactory
Reportcomplete
Reportincomplete
DCA
Input data & submit
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 and demand 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 the
potential for supplements to be prone to quality-control
problems
CONCLUSION
Authority to regulate and approve product registration and licensing through pre-market assessment helps
ensure that consumers have access to safe, high quality, properly labeled products.