Against the continuous implementation of the Regulations on the Supervision and Administration of Cosmetics and the Specifications for Evaluation of Cosmetic Efficacy Claims, human safety testing, efficacy evaluation and consumer use trials of cosmetics have become mandatory requirements for product registration and filing. Human trials are directly tied to the health and rights of trial subjects, yet the cosmetic industry has long lacked exclusive ethical review specifications tailored to cosmetic application scenarios.
Issued on June 15, 2026 and fully implemented on June 16 the same day, the Technical Guidelines for Ethical Review of Cosmetic Human Trials was initiated by the Chinese Association of Health Supervision and led in compilation by the Shanghai Center for Clinical Research, among other institutions. As a core drafting entity, EWISH participated in the research and formulation of this standard. Drawing on years of practical experience in human trials, EWISH delivered professional solutions, furnishing authoritative actionable benchmarks for the standardization of human research across the industry.
In recent years, the beauty industry has witnessed an explosive surge in demand for efficacy research and development. Nevertheless, cosmetic human trials differ fundamentally from clinical trials of pharmaceuticals and medical devices: cosmetic trials primarily recruit healthy volunteer subjects, cover a wide spectrum of product categories, and involve diverse testing scenarios, making the direct adoption of ethical review rules for pharmaceuticals and medical devices infeasible.
Concurrently, national ethical supervision has grown increasingly stringent. In 2023, four government authorities jointly issued the Measures for Ethical Review of Human-related Life Science and Medical Research, imposing mandatory requirements for the protection of human trial subjects. Historically, the industry has faced compliance risks including non-standard trial protocol design, simplified informed consent procedures, inadequate assessment of special populations (children, sensitive-skin groups), and insufficient privacy protection. A unified set of actionable technical guidelines aligned with cosmetic testing scenarios was therefore urgently needed.
This newly released group standard defines four core ethical principles: beneficence, non-maleficence, respect for persons, and justice. It sets out full-process review requirements covering three major trial categories: human safety testing, efficacy evaluation trials, and consumer use trials. The standard fundamentally standardizes human research practices within the industry and reinforces safeguards for the legitimate rights and interests of trial subjects.
As one of the core drafting organizations of the Guidelines, EWISH took part in the full development cycle. Leveraging its operational experience running standardized human trial laboratories, EWISH submitted key technical recommendations addressing practical industry pain points and provided extensive frontline implementation references for the formulation of standard provisions:
1. Refined ethical review detailed rules for special products based on full-category testing practice As a cosmetic testing institution filed with the National Medical Products Administration (NMPA), EWISH regularly conducts human testing for general cosmetics, special cosmetics and children’s cosmetics across all product categories. For high-risk testing scenarios involving new cosmetic raw materials, children’s skincare products and sensitive-skin formulations, EWISH submitted special proposals on safety assessment, risk grading and subject screening to the expert panel, which have been incorporated into key review clauses of the Guidelines to fill gaps in ethical control over special cosmetics.
2. Delivered actionable full-cycle protection protocols for trial subjects Backed by a standardized volunteer database of over 30,000 participants and a mature subject management system, EWISH supplied implementable process frameworks covering standardized informed consent templates, secure storage of subjects’ private data, emergency response protocols for adverse events, and unconstrained voluntary withdrawal mechanisms. This transforms the theoretical clauses of the Guidelines into directly deployable operational measures.
3. Established a standardized ethical management framework for third-party testing institutions Targeting differentiated demands across three types of entities—testing laboratories, in-house corporate R&D testing teams, and third-party evaluation organizations—EWISH organized standardized specifications for researcher qualification, laboratory premises and equipment, internal ethical self-inspection workflows, and traceable management of trial data. This resolves the industry-wide issue of inconsistent implementation standards among diverse organizations.
As the sole cosmetic efficacy evaluation inspection and testing center authorized by the China National Light Industry Council, EWISH adopts an objective third-party testing perspective to balance three core dimensions: regulatory compliance, corporate R&D demands, and subject rights protection, ensuring the standard integrates rigorous normative requirements with practical industry applicability.
The rollout of this group standard marks a milestone in the development of China’s ethical governance system for cosmetic human research. It translates theoretical regulatory requirements into implementable technical detailed provisions, serving as a reference basis for ethics committees, research institutions, testing and evaluation bodies, and cosmetic enterprises conducting human research.
Moving forward, EWISH will continue to leverage its technical strengths, relying on professional laboratories and expert teams to provide domestic beauty brands with compliant, scientific and efficient human efficacy and safety evaluation services, and support the high-quality innovative development of China’s domestic cosmetic industry.
