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CONTROL OF DIETARY

SUPPLEMENTS INMALAYSIA

CONTROL OF DIETARY

SUPPLEMENTS INMALAYSIA

TAN LIE SIE

DRUG EVALUATION AND SAFETY DIVISIONNATIONAL 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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What is this interface?

- interaction of 2 regulatoryregimes;

- no internationallystandardised approach;

- complex, with public health andsafety implications

FOOD/DRUG INTERFACE


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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

jVitamin

jmineraljamino acidjFatty acid

jFibre

jLyophilizedBacteriajEnzyme

yAlfalfa tablets

ySpirulinayRoyal Jelly

yNoni Juice

yPegaga tablet

yHerbal product

80% or more

Food base

Less than 80% food base or more

than 20% active ingredients of

natural products. But if the latterpossess 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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If a product contains less than 80% of food-based ingredients and more than 20% ofthe active ingredients, such product shallbe regulated by NPCB. Not withstandingthis general rule, for specific ingredientswhich possess high potencies, even if theycontain less than 20% of the active

ingredients, they shall be reviewed by thecommittee and may be regulated by NPCBif it is found necessary

FOOD/DRUG INTERFACE


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If a product is more than 80% food basedbut

contains pure forms of active ingredient(e.g.: vitamins & minerals) that exceed theamounts permitted in Food Regulations1985,

the company shall be advised to reduce the

amounts of these active ingredients and be

regulated by BKMM.

FOOD/DRUG INTERFACE


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Following criteria should not be used assole criteria for classification but can beused as a guide

Intended use and claim

Instruction for use and ph

armaceuticaldosage forms like tablet, capsule, etc

FOOD/DRUG INTERFACE


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DRUG CONTROL AUTHORITY

NATIONAL PHARMACEUTICAL

CONTROL BUREAU (NPCB)(as Secretariat / Executive Arm)


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DRUGCONTROLAUTHORITY

(DCA)

Register all drugs (prescription, over-the-

counter andh

erbal medicines) and cosmeticproducts

License manufacturers, importers andwholesalers of registered products

Monitor the quality and safety of marketedproducts through Post-Registration MarketSurveillance & Adverse Drug ReactionsReporting


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The Control ofDrugs and

Cosmetics Regulations 1984

Regulation 7(1)(a) requiresALLproducts to beregistered with the DCA prior to beingimported, manufactured, sold or supplied,unless the product is exempted under specific

provisions of these Regulations.


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Cosmetics Regulations 1984

A productas defined in the Regulations,means a drug in a pharmaceutical dosageform, or a cosmetic, having a singularidentity, composition, characteristics and

origin.


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Cosmetics Regulations 1984A drugis 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 orwell being


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DIETARYSUPPLEMENTS

Products intended to supplement the diet,taken by mouth in forms such as pills,

capsules, tablets, liquids or powders and notrepresented as conventional food.

May include ingredients such as

Vitamins, Minerals, Amino Acids,Natural Substances of plant/animal origin,Enzymes

Substances with nutritional / physiologicalfunction


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Why register dietary

supplements?

Need to protect consumer interests

* Record of products registered andtheir respective responsiblemarket authoriztion holders andmanufacturers

* Monitoring and enforcement* Regulate claims

* Safety aspects


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REGISTRATIONCRITERIA

SAFETY

Products will not be registered if there arepublic health concerns based on safetyconsiderations (ingredients used, combinations)

Upper daily limits set for some vitamins andminerals

Warnings/precautions may be required in

product labelling


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QUALITY

Have to comply with current Good ManufacturingPractices (cGMP) requirements

- infrastructure /facilities

- personnel

- processes and controls

Sh

ould conform to set standards of quality- raw materials

- finished product

- stability testing


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CLAIMS ( EFFICACY )

Supplements may not bear disease claims (ie

capable of curing, treating or preventingdisease); either explicit or implied

Allowed to be indicated as Dietary / Food/Nutritional Supplement

Function claims which describe thephysiological role of the nutrient in normalfunctioning of the body may be permitted


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REGISTRATIONPROCESS

On-line registration process (singlestage)

Implementation of the on-line registrationsystem :

1 July 20031 July 2003 - for pharmaceuticals(generics), and the OTC products

1 January 20041 January 2004 - for traditional products

1 Mac 20041 Mac 2004 - targeted date for the NCEand Biotech products


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Flow Chart of Registration Process

(Pre-market Approval)

Legal Requirements

Guidelines, Criteria,

Process (abridged)

Quality test fortraditional products

Obtain smart card

JKPP

Applicant

BPFK evaluate

application

Request for

additional info

Prepare evaluationreport

Request for

additional

info

Secretariat

Not

satisfactorySatisfactory

Report

complete

Report

incomplete

DCA

Input data & submit


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REGISTRATIONPROCESS

Unique registration no MAL20001198X

Registration for a maximum period of 5years

Updating of product information

Re-register before expiry of term to bemaintained on product register


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CONCERNS

Consumer perception that a product in theform of a medicineis perceived to be a drugfor treatment

Responsible information provision. There ispotential high risk to consumers as a result ofinsufficient or incorrect information, orfraudulent products.

- Although a product may not be toxic or

dangerous, consumers may compromise theirhealth by not seeking proper medicalattention.

- Claims about supplements should not divertattention away from eating a healthy diet


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CONCLUSION

There is tremendous interest in anddemand for health supplements and a

need for regulators to accommodateboth the industry and consumers in

this area.


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CONCLUSION

However the growing market for

supplements in a less restrictiveregulatory 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 licensingthrough pre-market assessment helpsensure that consumers have access tosafe, high quality, properly labeled

products.


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http: // www.bpfk.gov.my

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