Overview Overview –– Consumer Health ProductsConsumer Health Products Law and Compliance IssuesLaw and Compliance Issues

The First Asia Pacific Pharmaceutical Compliance CongressSeptember 2011

CHONG JIN NGAssistant General CounselAsia Shared Legal Services

Consumer Health Products

Agenda●

Overview of Applicable Law and Codes

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Current issues / Compliance Challenges

Categories Covered●

Over the Counter Medications (“OTCs”)

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Cosmetics

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Health/Dietary Supplements/Nutritionals

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Medical Devices

2

Framework for OTCs

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Increased incidence of self-medication

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Better public health through easy access (e.g. smoking cessation)

●

Savings in healthcare costs (resources used more efficiently)

3

OTCs: Regulatory Principles

Key Control Mechanisms

(a)

Proper labelling (to provide consumer with relevant information)

(API, Indications, Safety)

(b)

Advertising Control (via self or co-regulatory systems)

(Truthful claims, Not misleading)

(c)

Restrictions on retail outlets

4

OTCs

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Classification as a means of control

OTCs make medication more readily available without physician’s intervention

●

OTCs can be further classified generally into:

(i)

Pharmacy only

(ii)

General sales list

●

Rx products can also be reclassified (at manufacturer’s initiation) into OTC status

5

OTCs (cont’d)

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Subject to same general regulatory regime as drugs (marketing approval) (e.g. Drugs Act, Pharmaceutical Affairs Act)

●

Due to safer medical profile, manufacturer can typically request for waiver

of clinical data submission, subject to

meeting certain criteria.

●

Regulatory approval also utilises concept of reference agencies (Australia TGA, US FDA, UK MHRA) and standard reference texts (on the use of active ingredient)

6

OTCs (cont’d)

Industry Associations

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World Self-Medication Industry (WSMI)

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U.S.A –

CHPA (Consumer Healthcare Products Association)

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CHPA has its own voluntary code and guidelines

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Asia Pacific –

Australia, China, Taiwan, Indonesia, Japan, Korea, Malaysia and New Zealand

7

OTCs: Ongoing Issues

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Methamphetamine (“Meth”) and Pseudoephedrine (“PDE”) Abuse

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PDE widely used OTC decongestant which can be used to manufacture Meth

●

Meth illegal and highly addictive drug

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U.S legislation: Combat Meth Epidemic Act (2006)

8

Cosmetics

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Definition

A “Cosmetic Product”

is any substance of preparation that is intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them or keeping them in good condition.

-

Includes lotions, gels and oral care products

9

Cosmetics Regulatory Regime

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Often times, manufacturers market a cosmetic product (with drug/health claims) without adhering to drug regulatory laws.

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“Cosmeceutical”

–

a product which is both a drug and a cosmetic. No legal meaning but suggests that product may have some therapeutic effect.

10

Cosmetics Regulatory Regime (cont’d)

●

USA –

FDA is the regulatory authority

(i) Federal Food Drug & Cosmetic Act

(ii) Fair Packaging & Labelling Act

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Applicable Law

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ASEAN –

Cosmetic Directive

–

To harmonise the regulation of cosmetics in the region

–

Member states to ensure that only cosmetics which conform to Directive can be put onto the market.

–

Manufacturer/Supplier has obligation to notify relevant regulator of place of manufacture or of initial importation before general sale.

11

ASEAN Directive

●

Standardised

labelling

requirements

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Information required include the following:

−

Functions

−

Instructions for use

−

Full ingredients for listing

−

Manufacturing / Expiry date

−

Special precautions if any

12

Hot Issues

●

Poor compliance with advertising standards in certain segments:

(i)

efficiency claims for skin creams (cumulative claims)

(ii)

ultra-scientific claims (e.g. cell regeneration)

(iii)

“dermatologist tested”

claims (what does this really mean)

13

Health/Dietary Supplements/Regulatory Regime

●

Definition

Product that is taken by mouth and contains “dietary ingredient”

intended to supplement diet.

Dietary Ingredients (“DI”) include vitamins, minerals, herbs, amino acids, any substance to supplement diet by increasing total dietary intakes (e.g. enzymes)

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AP region: Regulatory regime governed by combination of:

–

Food Laws

–

Regulations from local FDA

–

Consumer Protection Laws14

Singapore: Health Supplements Guidelines

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Guidelines define Health Supplements to include:

(i)

Traditional Medicines

(ii)

Health Foods (with vague and general medicinal claims)

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Working Definition

−

A product used to supplement a diet, with benefits beyond those of normal nutrients, and/or to support/maintain healthy functions of the body.

−

No pre-marketing approval system in place.

15

HS: Claims Guidelines

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Claims must be consistent with definition of HS

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Cannot be advertised for medicinal purpose (treatment or prevention, implied or otherwise of any disease or disorder)

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Must not be misleading or which cannot be adequately substantial

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Labelling

Guidance

16

HS: Nutritional Health Claims (General)

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Permitted provided they contain well-documented ingredients which function is supported in standard reference texts and is adequately substantiated.

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Include (a) general health maintenance

(b) vitamin and/or mineral supplementation

(c) supports healthy function of human body

17

Medical Devices

18

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Definition

a product/device that is represented for use by humans or is part of a class of substances, preparations or devices intended for use by humans solely or principally for health-related purposes

Includes simple bandages, surgery equipment, medical diagnostic equipment

Regulatory Regime

19

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Not as complicated as pharmaceutical regulation.

●

Where regime is in place, marketing authorisations

are required. Classification system is risk-based.

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Various industry associations: e.g. AdvaMed

(Advance Medical Technology Association) but no single global association to cover entire industry.

Medical Devices: Compliance Issues

20

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Ethical collaboration with HCPs

to advance medical technology.

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HCP: innovators/having equity ownership.

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FCPA focus

Q&AThank You!