Transcript ACD Hamonization Presentation

ASEAN HARMONIZATION OF
COSMETIC REGULATIONS
OVERVIEW
Objectives
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To achieve high quality and safe products
in the market.
Help the products to penetrate global
markets.
Encourage self compliance and self
regulation.
Harmonization
10 ASEAN Member States
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Brunei
Cambodia
Indonesia
Lao PDR
Malaysia
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Myanmar
Philippines
Singapore
Thailand
Vietnam
ASEAN Harmonization Benefits
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The Consumers
A wider choice of cosmetic products
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The Government/Regulatory Bodies
One Simplified Regulatory System
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The Cosmetic Industry
ASEAN as one single market
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The ASEAN Region
Eliminate technical barriers to trade
Facilitate flow of products across ASEAN
Member Countries to boost economic growth
Republic Act No. 9711 or
FDA Act of 2009
General Provision:
The manufacturer, importation, exportation, sale,
offering for sale, distribution, transfer, non-consumer
use, promotion, advertising, or sponsorship of any
HEALTH PRODUCT without the proper
authorization from the FDA is prohibited. (Sec. 10,
RA 9711)
A manufacturer, owner, distributor, advertiser, and/or
their agents are mandated to strictly observe the
prohibitions and strictly adhere to the standards,
guidelines, and rules and regulations prescribed by
the FDA.
Republic Act No. 9711 or
FDA Act of 2009
Administrative sanctions and/or penalties:
 A fine of not less than Fifty Thousand Pesos
(PhP50,000), but not more than Five Hundred
Thousand Pesos (PhP500,000). An additional fine
of not more than One Thousand Pesos (PhP1,000)
shall be imposed for each day of continuing
violation.
 Destruction and/or appropriate disposition of the
subject HEALTH PRODUCT and/or closure of the
establishment for any violation of the FDA Act of
2009, these Rules and Regulations, other relevant
laws, and FDA-promulgated issuances. (Sec. 13,
RA 9711)
Definitions
Under Republic Act No. 9711, otherwise known as the
Food and Drug Administration (FDA) Act of 2009,
here are the definitions of terms related to ASEAN
Cosmetic Directive or ACD:
 Health Products – means food, drugs, cosmetics,
devices, biologicals, vaccines, in-vitro diagnostic
reagents and household/ urban hazardous
substances and/or a combination of and/or a
derivative thereof. It shall also refer to products that
may have an effect on health, which require
regulations as determined by the FDA.
Definitions
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Cosmetics – means any substance or preparation
intended to be placed in contact with the external
parts of the human body (epidermis, hair system,
nails, lips and external genital organs) or with the
teeth and the mucous membranes of the oral cavity
with a view exclusively or mainly to cleaning them,
perfuming them, changing their appearance and/or
correcting body odor and/or protecting the body or
keeping them in good condition.
Definitions
Cosmetic products are identified as follows:
 Cleansing
 Rubbed
 Beautifying
 Poured
 Promoting
 Sprinkled
Attractiveness
 Sprayed
 Altering the appearance
 Applied
Republic Act No. 9711 or
FDA Act of 2009
There will be four (4) Centers covering the four
(4) major product categories that are
regulated by FDA: Food, Drug, Cosmetics
and Device.
Under Cosmetic Center (includes household
hazardous/urban substances), there will be
Risk Management and Surveillance Division,
which will implement the Post-Market
Surveillance System.
Definitions
Post-Market Surveillance – means monitoring
health products and incidents of adverse events
involving such products in coordination with the FDA
Regional Field Offices.
They will develop and maintain a system for gathering
and monitoring information on health product risks
and actions. And to develop standards on risk
management to be followed by all manufacturers,
traders, distributors, importers, exporters,
wholesalers and retailers and, where applicable,
users of health products.
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Post-Market Surveillance of
Cosmetic Products
Factors that warrant inspection of cosmetic
establishment
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Company’s history of compliance
Regulatory authority’s surveillance
Market information and feedback from
consumers
Type and risk level of products
Consumer Complaints
Post-Market Surveillance of
Cosmetic Products
Subject of Audit and Sources of Samples
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Department
Stores
Supermarkets/
Public Markets/
Grocery Stores
Drugstores/
Pharmacies
Dermatological
Clinics
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Mall Shops,
Boutiques or
Stalls
Direst Selling
Spas
Beauty Salons
Hotels/Resorts
ASEAN HARMONIZED COSMETIC
REGULATORY SCHEME
The manufacturer/Importer/Distributor or the person
responsible for placing cosmetic products on the ASEAN
market, shall notify the cosmetic regulatory authority of
each Member State where the product will be marketed
of the place of manufacture or of the initial importation of
the cosmetic product before it is placed on the ASEAN
market, using the Product Notification Form prescribed
by the regulatory authority. The product can only be
marketed after notification has been sent to the
regulatory authority and acknowledgement has been
received.
ASEAN HARMONIZED COSMETIC
REGULATORY SCHEME
The implementation of ACD in the
Philippines started January 2008. The
Regulatory Agency allows the industries a
36-month grace period for compliance.
Full implementation of ACD for all
Member States : January 2011
Product Notification Guidelines
Requirements for Product Notification:
 Full ingredient listing (as per labeling requirements)
and the percentage of restricted ingredients.
 Copy of License to Operate of the company.
Acceptance of a product notification does not constitute, in any way,
an agreement that the product meets all the regulatory
requirements. The company or person responsible for placing the
product in the market has to ensure that each consignment of the
product meets the requirements of the Directive and will not cause
damage to human health under normal or reasonably foreseeable
conditions of use. The Regulatory Authority will require the company
to keep a Product Information File (PIF) and will carry out a range of
post-marketing monitoring and surveillance activities to ensure
compliance with the Directive.
PIF Guidelines
In view of the above ACD requirements, companies placing
products in the market need to organize the PIF in such a way
that it meets the requirements and be easily consulted by the
Authorities. It is recommended that the PIF be organised into 4
parts as follows:
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Part I:
Part II:
Part III:
Part IV:
Administrative Documents and Product Summary
Quality Data of Raw Material
Quality Data of Finished Product
Safety and Efficacy Data
A Table of Contents should be provided for each of the 4 parts.
PIF Guidelines
In the fourth and final part of the PIF, the Companies are required to
provide Safety and Efficacy Data, which shows detailed
information on the safety assessment and data of the finished
product and also relevant efficacy data to support any claims
made on the product, conducted by a certified Safety Assessor
and Dermatology.
There are specific Test and corresponding Fees involve for the
Safety and Efficacy Assessment:
 Dermal Patch Test (for allergic reaction/irritancy) - Php15,000 per
product
 Clinical Study (for justification of claims) – Php35,000 per product
FDA Expectations to the
Cosmetic Industry
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Company to closely coordinate with the
authority to safeguard the safety of the
consumers (vise-versa)
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Request Industry Association to collaborate
with the authority for the dissemination of
new policies and updates on ACD to their
members
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Company to policing their own brand to
lessen the counterfeit products in the market
FDA Expectations to the
Cosmetic Industry
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Company to strengthen the undesirable event
reporting for the welfare of the consumer
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Company to place their cosmetic product in
accordance with the GMP and ACD
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Company to help BFAD reach those SMEs to
participate in the ASEAN Harmonization of
Cosmetic and to compete in the global
market
Solutions to the Cosmetic Industry
There are ways to prevent and encounter these
situations with FDA:
 Transact business with establishments that are
accredited/licensed by FDA.
 They should have valid License to Operate and/or
GMP Certificate.
 They should have valid authorizations/notifications
issued by FDA for the products they market.
 They should be compliant to the Rules and
Regulations of ASEAN Cosmetic Directives, e.g.
PIF, SOP, etc.