Definitions and basic principles of clinical trial tests of cosmeticsis
Test(hereinafter referred to as “the test”) conducted to examine the clinical effects of the cosmetics for the purpose of demonstrating the safety and effectiveness of cosmetics and to examine harmful cases
The safety and welfare of the subject are more important than the profits of science and society
Clinical trial tests should be conducted in accordance with the ethical rules, applicable guidelines and relevant provisions of the Helsinki declaration
Clinical trial test shall be scientifically valid and the plan and report shall be clear and should be described in detail.
The medical service given to the subjects or decision making of the subjects must be done under doctor’s reponsibility
Everyone involved in the clinical trial testing must have appropriate training experience to perform their tasks.
Prior to participating in the testing, all participants should have a voluntary participation in clinical trials.
All information related to the clinical trial test should be recorded, processed and preserved to enable accurate reporting, interpretation, and verification
All records of the subject’s identity must be treated in accordance with the relevant provisions to ensure confidentiality
The safety of cosmetics (or substances) should be proved before conducting the test
Clinical trial tests should be conducted under a system that ensures reliability
Subject matter not specified in other guidelines should be in accordance with pharmaceutical laws and regulations and clinical trial management standards.