Title: MALAYSIA: PRODUCT REGISTRATION AND REGULATION
1 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
2 CONTENTS
- Food / Drug Interface
- Regulatory Process in Malaysia
-
- Concerns
- Conclusion
3FOOD/DRUG INTERFACE
- What is this interface?
- - interaction of 2 regulatory regimes
- - no internationally standardised approach
- - complex, with public health and safety
implications
4 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
- Alfalfa tablets
- Spirulina
- Royal Jelly
- Noni Juice
- Pegaga tablet
- Herbal product
- Vitamin
- mineral
- amino acid
- Fatty acid
- Fibre
- LyophilizedBacteria
- Enzyme
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.
5FOOD/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
6FOOD/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.
7FOOD/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 -
8DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICAL CONTROL BUREAU
(NPCB) (as Secretariat / Executive Arm)
9DRUG 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
10The 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.
11The 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.
12The 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
13DIETARY 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
14Why 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
15REGISTRATION 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
16REGISTRATION 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
17REGISTRATION 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
18REGISTRATION 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
19Flow Chart of Registration Process (Pre-market
Approval)
Applicant
- Legal Requirements
- Guidelines, Criteria,
- Process (abridged)
- Quality test for traditional products
Obtain smart card
Input data submit
BPFK evaluate application
Not satisfactory
Request for additional info
Satisfactory
Prepare evaluation report
Request for additional info
Report incomplete
Report complete
Secretariat
DCA
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22REGISTRATION 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
23CONCERNS
- 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
24CONCLUSION
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.
25CONCLUSION
However the growing market for supplements in a
less restrictive regulatory environment creates
the potential for supplements to be prone to
quality-control problems
26CONCLUSION
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.
27http // www.bpfk.gov.my