化妆品功效宣称评价试验的伦理审查

Ethical review of cosmetic efficacy claims evaluation trails

中国对化妆品的监管起步较晚,与之配套的伦理审查相关法规尚不完善。2021年1月1日起实施的《化妆品监督管理条例》对化妆品功效宣称有了更加严格的要求,要求化妆品的功效宣称应当有充分的科学依据。化妆品功效宣称评价试验包括人体功效评价试验、消费者使用测试和实验室试验。人体功效评价试验和消费者使用测试应当遵守伦理学原则要求,进行试验之前应当完成必要的产品安全性评价,确保在正常、可预见的情况下不得对研究参与者(或消费者)的健康产生危害。《化妆品注册备案资料管理规定》要求产品检验报告应包括微生物与理化检验、毒理学试验、人体安全性试验报告和人体功效试验报告等。伦理委员会审查化妆品功效宣称评价试验的要点包括试验方案的合理性、消费者调查和专家评价、检测方法的选择、研究人群和样本量、化妆品的安全性评价、化妆品原料的风险评估、隐私保护、检测机构和研究人员的资质。高质量的伦理审查有助于维护研究参与者(或消费者)的安全和权益,也将助推中国化妆品功效宣称评价试验的质量。

The supervision of cosmetics started relatively late in China,and corresponding laws and regulations on ethical review are not yet perfect.The Cosmetics Supervision and Administration Regulations,which came into force on January 1,2021,had stricter requirements for cosmetic efficacy claims,requiring that cosmetic efficacy claims should have a sufficient scientific basis.Cosmetic efficacy claims evaluation trials include human efficacy evaluation trials,consumer use tests,and laboratory trials.Human efficacy evaluation trials and consumer use tests should comply with the requirements of ethical principles,the necessary product safety evaluation should be completed before the tests are carried out,to ensure that there is no harm to the human health of research participants(or consumers)under normal,foreseeable circumstances.The Regulations on the Administration of Registration and Filing Materials for Cosmetics required that product test reports should include microbiological and physical-chemical tests,toxicological trials,human safety trial reports,and human efficacy trial reports.The key points of the ethics committee’s review of cosmetic efficacy claims evaluation trials include the reasonableness of the trial protocol,consumer survey and expert evaluation,selection of detection methods,study population and sample size,safety evaluation of the cosmetics,risk assessment of cosmetic raw materials,protection of privacy,and qualifications of the testing institutions and researchers.High-quality ethical review is conducive to safeguarding the safety and rights of research participants(or consumers),and will also promote the quality of cosmetic efficacy claims evaluation trails in China.