MALAYSIA: PRODUCT REGISTRATION AND REGULATION

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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
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CONTENTS

• Food / Drug Interface
• Regulatory Process in Malaysia
• Concerns
• Conclusion

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FOOD/DRUG INTERFACE

• What is this interface?
• - interaction of 2 regulatory regimes
• - no internationally standardised approach
• - complex, with public health and safety
  implications

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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

• 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.

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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

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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.

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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

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DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICAL CONTROL BUREAU
(NPCB) (as Secretariat / Executive Arm)
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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 Post-Registration Market
  Surveillance Adverse Drug Reactions Reporting

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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.
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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.
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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

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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

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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

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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

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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

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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

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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

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Flow 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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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

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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

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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.
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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
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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.
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http // www.bpfk.gov.my