Page 16 - 2018食藥署年報(英文版)

4. Cosmetics management framework

The current cosmetics management system is divided into production source control, pre-
market management, and post-market surveillance. (Figure 1-6) Source control management
includes ensuring that manufacturers comply with Establishment Standards for Cosmetics
Manufactory and promoting voluntary Good Manufacturing Practice (GMP) for cosmetics. Pre-
market management includes registrations of medicated cosmetics. And post-market surveillance
focuses on implementing cosmetics quality surveillance programs with joint audits spanning

multiple counties and cities, establishing a product adverse event reporting system for cosmetics,
monitoring of domestic and global cosmetic safety alerts regularly, and strengthening consumer
awareness of safe cosmetics use to create a comprehensive cosmetics quality and safety protection
network.

Source Factory Pre-market Post-market Consumer communication
and education
management
◆ Factory registration.
Market Consumer
◆ Establishment Standards
for Cosmetics Manufac- ◆ Pre-market review of
tory. medicated cosmetics
◆ Voluntary GMP. Product
management
◆ Joint audit and sampling of marketed ◆ Report of adverse events of
product
cosmetic
◆ Domestic and global safety monitoring ◆ Promotion of proper use
and vigilance for consumers
◆ Advertisement monitoring

Figure1-6 Cosmetics management framework

Note: The amended draft of the Cosmetic Hygiene and Safety Act was reviewed and approved
by the Social Welfare and Environmental Hygiene Committee of the Legislative Yuan on December
20, 2017. On December 29 of the same year, the Legislative Yuan decided to send the draft for
negotiation among party caucuses. The amendment was announced by the President through the Hua-
Zong(I)-I-Zi No. 10700045851 order on May 2, 2018, with the enforcement date to be determined
by the Executive Yuan. In the future, the term “medicated cosmetics” will be changed to “specific
purpose cosmetics” and the product notification and product information file will replace the existing
pre-marketing registration system for medicated cosmetics. There is a five-year transition period in
place for the switch from the registration system to the new one.

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