CONTROL OF DIETARY SUPPLEMENTS IN MALAYSIA TAN LIE SIE DRUG EVALUATION AND SAFETY DIVISION NATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA.

CONTROL OF DIETARY

SUPPLEMENTS IN MALAYSIA

CONTROL OF DIETARY

SUPPLEMENTS IN MALAYSIA

TAN LIE SIE

DRUG EVALUATION AND SAFETY DIVISIONNATIONAL PHARMACEUTICAL CONTROL BUREAU

MINISTRY OF HEALTH MALAYSIA

Seminar on dietary supplements - 15 January 2004

CONTENTS

Food / Drug Interface

Regulatory Process in Malaysia

Concerns

Conclusion

What is this interface? - interaction of 2

regulatory regimes; - no internationally

standardised approach; - complex, with public

health and safety implications

FOOD/DRUG INTERFACE

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

Vitaminmineralamino acidFatty acidFibreLyophilizedBacteriaEnzyme

Alfalfa tabletsSpirulinaRoyal JellyNoni JuicePegaga tabletHerbal product

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.

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 butcontains 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 beregulated by BKMM.

FOOD/DRUG INTERFACE

Following criteria should not be used assole 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

FOOD/DRUG INTERFACE

DRUG CONTROL AUTHORITY

NATIONAL PHARMACEUTICALCONTROL 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 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 singularidentity, composition, characteristics and origin”.

The Control of Drugs and Cosmetics

Regulations 1984A 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 1 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 NCE and Biotech products

Flow Chart of Registration Process (Pre-market Approval)

Legal Requirements Guidelines, Criteria, Process (abridged) Quality test for

traditional products

Obtain smart card

JKPP

Applicant

BPFK evaluate application

Request for additional info

Prepare evaluation report

Request for additional

info

Secretariat

Not satisfactory

Satisfactory

Reportcomplete

Reportincomplete

DCA

Input data & submit

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 pre-market assessment helps

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

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