Transcript MALAYSIA: PRODUCT REGISTRATION AND REGULATION

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 foodbased 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)


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Register all drugs (prescription, over-thecounter 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 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

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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
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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)
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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
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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

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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.
http: // www.bpfk.gov.my