药妆品的定义及法规定位

COSMECEUTICALS IN JAPAN
CoΒιβλιοθήκη Baidumetics—Quasi—Drug
Pre market registration Safety and Efficacy data Enlarging cateloge Ingredients administration
COSMECEUTICALS IN CHINA
Cosmetics—OTC—Drug
Claims and Labeling Ingredients administration Hair growing Pr：Minoxidil
COSMECEUTICALS IN E.U.
Cosmetics——Drug
Active Cosmetics Medicalized Cosmetics Claims and Labeling Safety responsibility
— Section 201 (321) (i), 1938, US
Drug：Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man and animals. Articles ( other than food ) intended to affect the structure or any function of the body of man or other animal and the ingredients entering into their composition. 《Federal Food, Drug, and Cosmetic Act》
— Section 201 (321) (i), 1938, US
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The definition of Cosmetics is out of date. It has been adopted principally worldwide. Changing the definition proved to be great difficult.
COSMECEUTICALS IN CHINA
REGULATORY UPDATES AND LATEST POLICIES
LIU Wei, Prof., M.D.
Department of Dermatology The General Hospital of Air Force Vice-Chairma of NSCC, MOH , China
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Illegal using of substances
Methenamine (INN) 乌洛托品
THE FUTURE OF COSMECEUTICALS
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Steinberg（US）OK, Regulation needed. Dweek（UK）Refused，should be drug Writtern(EU）OK, should be cosmetics Umbach（G）OK，future cosmetics. Takamatsu（J）OK, product Existed.
EFFICACY TESTS OF COSMECEUTICALS
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Development of new product Proper claims and labeling Using reference for consumers Administration and surveillance Cosmetic dermatology
Cosmetics—SUC—Drug
Pre market registration Safety data required Claims and Labeling Ingredients administration
The problems of SUC in China
Conflict with the cosmetic concept ● Inconsistent with the administration
WHAT IS COSMECEUTICALS? Cosmetics：化妆品
Pharmaceuticals：药品
Cosmeceuticals： 药妆品
Cosmeceuticals?
Albert Kligman （1970s)
Products having characters of both cosmetics and some drugs, or products between cosmetics and drugs.
COSMECEUTICALS SHOULD BE ……
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Regulated as Cosmetics or an independent product, not Drug. Both the safety and efficacy of cosmeceuticals should be concerned. Consistent definition, category and administration need to be made internationally.
Following consequences
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Inconsistent administration Threaten health of consumers Negative effect on the developing of market economy
COSMECEUTICALS IN U.S.
Problems of Cosmeceuticals market in present China
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OTC or Quasi in Cosmetic market Cosmetics pre market registration Efficacy claims and labeling
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Liu Wei, MD. Dept. Dermatology General Hospital of Air Force Beijing 100036, China Tel: 0086-10-66928074 E-mail: lwei5811@yahoo.com.cn
NO AUTHORITATIVE TERM
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Cosmeceuticals
Therapeutic Cosmetics
Functional Cosmetics
Functional Skin Care Products Active Cosmetics Special using Cosmetics
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Safety responsibility Difficult in ingredient control Limited classification Product efficacy confirmation
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Hair growing Cosmetics Whitening Cosmetics Deodouring Cosmetics Breast beautifying Cosmetics Slendering Cosmetics Molting Cosmetics Sunscreens Cosmetics Hair dying Cosmetics Hair Perming Cosmetics
WHY?
Cosmetics：Articles to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and the ingredients entering into their composition. 《Federal Food, Drug, and Cosmetic Act》
WHAT WE KNOW TODAY ?
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Existing worldwide as an intermediate product between Cosmetics and Drug； Representing the benefit of both the industry and consumers ； The regulations are out of date and the market administrations are not consistent worldwide ； The situation is conflict with the international harmonization of cosmetic regulation.