Page 19 - 2023 Taiwan Food and Drug Administration Annual Report

1Organization

and Policies

dealers and products circulation management. the Establishment Standards for Cosmetics
The system can effectively manage the safety, Manufactory and the Good Manufacturing
effectiveness, and quality of medical devices Practice (GMP); pre-market management
while facilitating the development of the consists of product notification and the
domestic biotechnology and pharmaceutical establishment of a product information file
industry, so as to create a win-win situation to replace in the 5-year transition period the
for consumers, business operators, and the registration for specific-purpose cosmetics;
government. post-market supervision, on the other hand,
focuses on quality monitoring and cross-
II. Cosmetics Management county/city joint inspections, establishment
framework of a reporting system for adverse events
of cosmetic products, regular monitoring
The current cosmetics management of domestic and overseas safety warnings,
system includes three parts: source control communications to consumers on the safe use,
for production, pre-market management, and construction of a comprehensive safety
and post-market supervision (Figure 1-8). and quality network of cosmetics.
Source control for production includes the
requirements for manufacturers to fulfill

• Factory registration Pre-market Post-market Consumer
• Establishment standards communication
• Cosmetics Good Manufac- and education

turing Practice

Source • Product notification Market Consumers
management • Pre-market registration of
• Cosmetics quality • Safety education for
Product specific-purpose cosmetics supervision consumers
management (5 years transition period)
• Cosmetics safety • Communication with the
• Product information file supervision public

• Product information file • Reporting of serious
and factory inspection adverse events and hygiene
and safety hazards

Figure 1-8 Cosmetics hygiene and safety management framework

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