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2015 Annual Report

55

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Food

Management

Medicinal

Products

Management

Policy and

Organization

Controlled

Drugs

Management

Medical

Devices

Management

Cosmetics have become indispensable in our daily lives, giving rise to public concerns on cosmetics

quality and whether long-term use may threaten human health and safety. Current cosmetics

management system is divided into three parts, namely production source control, premarket

management, and post-market surveillance (Figure 6-1). Source control includes ensuring the

compliance of manufacturers to the criteria for construction and establishment of a factory as well

as encouraging Voluntary Cosmetics Good Manufacturing Practice (GMP) for cosmetics. Premarket

management includes registration of medicated cosmetics and preliminary examination of cosmetic

advertisements. Post-market surveillance focuses on implementing cosmetics quality surveillance

projects, multi-county and city joint audits, establishing cosmetic products adverse events reporting

system, regular monitoring of domestic and global cosmetic safety alerts, and strengthening

consumer awareness for safe use of cosmetics. Together, these three parts will help create a

comprehensive cosmetics quality and safety protection network.

6

Seciton 1 Cosmetics Regulations and Product Review

Current Status

Rules prescribed by the current

Statute for Control of Cosmetic Hygiene

include premarket

inspection registration systems for medicated cosmetics as well as application systems for cosmetic

advertisements. Currently, approval for these items exceeds 90%. In recent years, the distribution of

cosmetics in global markets has become more widespread and flexible. EU and ASEAN countries

currently lack premarket review procedures for cosmetic products. To harmonize administrative

regulations and hygiene standards of cosmetics with international regulations and to promote further

development for the cosmetic industry, TFDA has referenced cosmetic regulations and management

systems adopted in other countries with the aim of lifting requirements for premarket inspection and

registration of cosmetics as well as preliminary examination of cosmetic advertisements. Currently,

TFDA has planned to establish a premarket registration and product information file (PIF) system,

implement GMP for cosmetics across the board, strengthen post-market surveillance and cosmetic

company management to ensure the comprehensiveness of cosmetic management systems.

Product

Premarket

management

Production

Source Control

Postmarket

surveillance

Inspection and registration

of medicated cosmetics

Preliminary examination of

cosmetic advertisements

Cosmetics quality surveillance program and

multi-county and city joint inspections

Cosmetic products adverse events

reporting system Monitoring of

domestic and global safety alerts

Improving awareness of safe use of cosmetics

Voluntary cosmetic GMP

The criteria for construction

and establishment of a

factor

Cosmetics Management

Figure 6-1

Current cosmetic management framework