Page 79 - 2020Taiwan Food and Drug Administration Annual Report

sessions for the draft of sub-regulations since 2013 and will continue to conduct more related
sessions in the future, to assist the businesses to understand the new laws.
II. TFDA has stipulated the “Regulations Governing Notification of Cosmetic Products” with
reference to the regulations of the European Union and the ASEAN. Starting from July 1,
2021, the registration and management system for general cosmetics and specific-purpose
cosmetics will be implemented in two stages. The “Regulations for Cosmetic Product
Information File Management” was also stipulated. As it is a new management system, we
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III. The GMP will be implemented by three phases starting from July 1, 2024 to facilitate
the implementation of quality management for cosmetic manufacturers, and based on the
different cosmetic categories the cosmetic manufacturing sites should follow the relevant
GMP regulations including newcomers. In addition, we stipulated the “Regulations for
Qualifications and Training of Cosmetics Professional Technicians,” to enhance the
professional knowledge of cosmetics supervisors to ensure that the product manufacturing
processes are under professional supervision and management.

IV. We stipulated the “Regulations for Cosmetics Recall” and the “Regulations Governing the
Source and the Flow Data of Cosmetic Products” to establish the recall management system
of cosmetics in Taiwan; we also regulated the cosmetics businesses to establish and maintain
data on direct supply sources and destinations of products.
V. To enhance the safety of the cosmetics, we stipulated the “Regulations for Reporting
Cosmetics Serious Adverse Effects and Hazards to Hygiene and Safety.´ ,W LV FOHDUO\ VSHFL¿HG
and requested that the cosmetics businesses should report to TFDA via the system of the post-
market quality management for medicinal products, food, and cosmetics when serious adverse
effects of consumers happen under the regular use of cosmetics, or the products may pose

hygiene and safety hazard or risks of harm, to provide the accurate information to the health
agency to investigate immediately.
VI. To regulate cosmetics advertisements and the declaration of false products, TFDA worked
with relevant departments, health bureaus of counties and cities, public associations, and
consumer protection associations to stipulate the “Regulations Governing Criteria for the
Label, Promotion, Advertisement with Deception, Exaggeration, or Medical efficacy of
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supplemented by positive and negative examples; in order to encourage the public and internal
employees to report illegal cosmetics circumstances, TFDA has discussed with the health
bureaus of counties and cities to stipulated the “Regulations on Cosmetic Hygiene and Safety
Violation Report and Reward.”

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