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Transcript of Slides TanLie Sie
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CONTROL OF DIETARY
SUPPLEMENTS INMALAYSIA
CONTROL OF DIETARY
SUPPLEMENTS INMALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISIONNATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA
Seminar on dietary supplements - 15 January 2004
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CONTENTS
Food / Drug Interface
Regulatory Process in Malaysia
Concerns
Conclusion
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What is this interface?
- interaction of 2 regulatoryregimes;
- no internationallystandardised approach;
- complex, with public health andsafety implications
FOOD/DRUG INTERFACE
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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
jVitamin
jmineraljamino acidjFatty acid
jFibre
jLyophilizedBacteriajEnzyme
yAlfalfa tablets
ySpirulinayRoyal Jelly
yNoni Juice
yPegaga tablet
yHerbal product
80% or more
Food base
Less than 80% food base or more
than 20% active ingredients of
natural products. But if the latterpossess 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.
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If a product contains less than 80% of food-based ingredients and more than 20% ofthe active ingredients, such product shallbe regulated by NPCB. Not withstandingthis general rule, for specific ingredientswhich possess high potencies, even if theycontain less than 20% of the active
ingredients, they shall be reviewed by thecommittee and may be regulated by NPCBif it is found necessary
FOOD/DRUG INTERFACE
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If a product is more than 80% food basedbut
contains pure forms of active ingredient(e.g.: vitamins & minerals) that exceed theamounts permitted in Food Regulations1985,
the company shall be advised to reduce the
amounts of these active ingredients and be
regulated by BKMM.
FOOD/DRUG INTERFACE
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Following criteria should not be used assole criteria for classification but can beused as a guide
Intended use and claim
Instruction for use and ph
armaceuticaldosage forms like tablet, capsule, etc
FOOD/DRUG INTERFACE
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DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICAL
CONTROL BUREAU (NPCB)(as Secretariat / Executive Arm)
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DRUGCONTROLAUTHORITY
(DCA)
Register all drugs (prescription, over-the-
counter andh
erbal medicines) and cosmeticproducts
License manufacturers, importers andwholesalers of registered products
Monitor the quality and safety of marketedproducts through Post-Registration MarketSurveillance & Adverse Drug ReactionsReporting
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The Control ofDrugs and
Cosmetics Regulations 1984
Regulation 7(1)(a) requiresALLproducts to beregistered with the DCA prior to beingimported, manufactured, sold or supplied,unless the product is exempted under specific
provisions of these Regulations.
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The Control ofDrugs and
Cosmetics Regulations 1984
A productas defined in the Regulations,means a drug in a pharmaceutical dosageform, or a cosmetic, having a singularidentity, composition, characteristics and
origin.
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The Control ofDrugs and
Cosmetics Regulations 1984A drugis 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 orwell being
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DIETARYSUPPLEMENTS
Products intended to supplement the diet,taken by mouth in forms such as pills,
capsules, tablets, liquids or powders and notrepresented as conventional food.
May include ingredients such as
Vitamins, Minerals, Amino Acids,Natural Substances of plant/animal origin,Enzymes
Substances with nutritional / physiologicalfunction
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Why register dietary
supplements?
Need to protect consumer interests
* Record of products registered andtheir respective responsiblemarket authoriztion holders andmanufacturers
* Monitoring and enforcement* Regulate claims
* Safety aspects
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REGISTRATIONCRITERIA
SAFETY
Products will not be registered if there arepublic health concerns based on safetyconsiderations (ingredients used, combinations)
Upper daily limits set for some vitamins andminerals
Warnings/precautions may be required in
product labelling
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REGISTRATIONCRITERIA
QUALITY
Have to comply with current Good ManufacturingPractices (cGMP) requirements
- infrastructure /facilities
- personnel
- processes and controls
Sh
ould conform to set standards of quality- raw materials
- finished product
- stability testing
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REGISTRATIONCRITERIA
CLAIMS ( EFFICACY )
Supplements may not bear disease claims (ie
capable of curing, treating or preventingdisease); either explicit or implied
Allowed to be indicated as Dietary / Food/Nutritional Supplement
Function claims which describe thephysiological role of the nutrient in normalfunctioning of the body may be permitted
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REGISTRATIONPROCESS
On-line registration process (singlestage)
Implementation of the on-line registrationsystem :
1 July 20031 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 NCEand Biotech products
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Flow Chart of Registration Process
(Pre-market Approval)
Legal Requirements
Guidelines, Criteria,
Process (abridged)
Quality test fortraditional products
Obtain smart card
JKPP
Applicant
BPFK evaluate
application
Request for
additional info
Prepare evaluationreport
Request for
additional
info
Secretariat
Not
satisfactorySatisfactory
Report
complete
Report
incomplete
DCA
Input data & submit
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REGISTRATIONPROCESS
Unique registration no MAL20001198X
Registration for a maximum period of 5years
Updating of product information
Re-register before expiry of term to bemaintained on product register
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CONCERNS
Consumer perception that a product in theform of a medicineis perceived to be a drugfor treatment
Responsible information provision. There ispotential high risk to consumers as a result ofinsufficient or incorrect information, orfraudulent products.
- Although a product may not be toxic or
dangerous, consumers may compromise theirhealth by not seeking proper medicalattention.
- Claims about supplements should not divertattention away from eating a healthy diet
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CONCLUSION
There is tremendous interest in anddemand for health supplements and a
need for regulators to accommodateboth the industry and consumers in
this area.
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CONCLUSION
However the growing market for
supplements in a less restrictiveregulatory environment creates the
potential for supplements to be prone
to quality-control problems
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CONCLUSION
Authority to regulate and approve
product registration and licensingthrough pre-market assessment helpsensure that consumers have access tosafe, high quality, properly labeled
products.
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http: // www.bpfk.gov.my