Page 61 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 5. Cosmetics Management
The current cosmetics management system is divided into production source control, pre-
market management, and post-market surveillance (Figure 2-5-1). Source control includes
ensuring manufacturers comply with Establishment Standards for Cosmetics Manufactory
and promoting voluntary cosmetic Good Manufacturing Practice (GMP) for cosmetics. Pre-
market management includes registration of medicated cosmetics and examination of cosmetic
advertisements before broadcasting. Post-market surveillance focuses on implementing cosmetics Part II - Key Administrative Results Cosmetics Management
quality surveillance programs, joint audits spanning multiple counties and cities, establishing a
product adverse event reporting system for cosmetics, regular monitoring of domestic and global
cosmetic safety alerts, and strengthening consumer awareness of safe cosmetics use to create a
comprehensive cosmetics quality and safety protection network.

Consumer
Source Pre-market Post-market communication
and education

Factory setup
and registration Factory
management
Voluntary GMP
Pre-market review of
medicated cosmetics
Cosmetic advertisement Market Consumer
examination
Joint audit and quality Recall reporting for
monitoring of marketed defective cosmetic products
Product products
Management Promotion of proper use
Domestic and global safety
monitoring and vigilance for
consumers
Advertisement monitoring

Figure 2-5-1 Cosmetics life cycle management

Section 1. Cosmetics Regulations and Product Review

Current Status
Current practices of cosmetics management in Taiwan are divided into medicated cosmetics
(which must be registered prior to marketing) and regular cosmetics. Cosmetic advertisements
must be pre-approved before broadcasting. However, countries in the EU and ASEAN as well as
the US currently employ routine inspections to replace pre-market reviews of products, and have
been able to effectively direct management resources to market surveillance. To better align with
international regulations, achieve effective monitoring of product quality and safety, maintain
the hygiene and safety of cosmetic products, and safeguard the public health, TFDA has
referenced cosmetic management systems around the world to reform the cosmetic hygiene
management system.

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