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SUPPLEMENTS IN
MALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISION
NATIONAL PHARMACEUTICAL CONTROL BUREAU
CONTENTS
Concerns
Conclusion
FOOD/DRUG INTERFACE
Ingredients
Vitamin
mineral
amino acid
Fatty acid
Fibre
LyophilizedBacteria
Enzyme
Alfalfa tablets
Spirulina
Royal Jelly
Noni Juice
Pegaga tablet
Herbal product
Food base
80% or more
Food base
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
FOOD/DRUG INTERFACE
FOOD/DRUG INTERFACE
Following criteria should not be used as
sole criteria for classification but can be
used as a guide
NATIONAL PHARMACEUTICAL
CONTROL BUREAU (NPCB)
(as Secretariat / Executive Arm)
DIETARY
SUPPLEMENTS
REGISTRATION CRITERIA
SAFETY
REGISTRATION CRITERIA
QUALITY
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
BPFK evaluate
application
Satisfactory
Not
satisfactory
Request for
additional info
Prepare evaluation
report
JKPP
Report
complete
Report
incomplete
Secretariat
Request for
additional
info
DCA
Legal Requirements
Guidelines, Criteria,
Process (abridged)
Quality test for
traditional products
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
CONCLUSION
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 premarket assessment helps
ensure that consumers have
access to safe, high quality,
properly labeled products.
http: // www.bpfk.gov.my