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CONTROL OF DIETARY

SUPPLEMENTS IN
MALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISION
NATIONAL PHARMACEUTICAL CONTROL BUREAU

MINISTRY OF HEALTH MALAYSIA

Seminar on dietary supplements - 15 January 2004

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


ingredient (singly or in
combination)

Vitamin
mineral
amino acid
Fatty acid
Fibre
LyophilizedBacteria
Enzyme

Natural product that are not


traditionally used as food and of
medicinal value

Alfalfa tablets
Spirulina
Royal Jelly
Noni Juice
Pegaga tablet
Herbal product

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

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-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 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 INTERFACE
Following criteria should not be used as
sole 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

DRUG CONTROL AUTHORITY

NATIONAL 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 PostRegistration 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 productas defined in the
Regulations, means a drug in a
pharmaceutical dosage form, or a
cosmetic, having a singular
identity, composition, characteristics
and origin.

The Control of Drugs


and Cosmetics
Regulations
1984
A 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

Input data & submit

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

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 premarket assessment helps
ensure that consumers have
access to safe, high quality,
properly labeled products.

http: // www.bpfk.gov.my