Regulation Updates in China
By Yiguang Zhu and Zachary Leibowitz | September 5th, 2024
A wave of regulatory updates in China is reshaping the landscape of the field of animal testing, challenging long-standing practices and opening doors to innovative non-animal alternatives. From advanced technologies to revised testing requirements, China is navigating a complex path that balances scientific rigor with growing concerns for animal welfare.
The National Medical Products Administration (NMPA), the Chinese equivalent of the U.S Food and Drug Administration (FDA), states in multiple guidance documents that, “Where relevant animal models are unavailable, cell and tissue-based models (e.g., 2D or 3D tissue models, organoids, microfluidic models) may be used to provide supplementary information for efficacy and safety assessments.” This official recognition of alternative testing methods has galvanized researchers, pharmaceutical companies, and other stakeholders in China to invest in the field.
Organ-on-a-chip (OOC) is one of the most promising technologies to emerge from this investment. OOC technology is revolutionizing drug development in China and offering more efficient and more human-relevant alternatives to traditional animal testing. Recent successes highlight its impact in various therapeutic areas. A heart disease drug advanced to clinical trials after successful screening on human heart-on-chip models. Tumor organoid-on-chip models have supported the screening and development of a cancer therapy for malignant solid tumors. Additionally, OOC technology has aided in the development of a CAR-T cell therapy for liver cancer. The resulting efficacy data has been included in IND applications to NMPA. These cases underscore NMPA's growing acceptance of OOC and OOC-derived data, which signals a shift towards more innovative, ethical, and human-relevant approaches in China's drug development landscape.
Building on the wave of regulatory changes, professional committees in China have been proactively developing expert consensus to standardize and promote the use of alternative testing methods. So far, there are 5 consensuses covering a wide range of applications, from cervical cancer organoids to drug sensitivity testing for precision oncology. These consensuses not only emphasize the crucial role of organoids in drug sensitivity testing but also formally recommend organoids as an innovative tool in the drug development process. These expert consensuses provide standardization and guidance for organoid technology in various clinical scenarios. The input from scientific societies is bridging the gap between regulatory acceptance and practical implementation, addressing the challenges faced by stakeholders in adopting these new technologies while ensuring compliance with evolving regulatory standards.
Beyond the pharmaceutical and biotechnology industries, China's cosmetics industry is also witnessing significant changes in its testing regulations. The Administrative Provisions on the Dossier of Registration and Notification of New Cosmetic Ingredients published in May 2021, waived animal testing for imported general cosmetics (e.g., shampoos, shower gels, perfumes), but special-use cosmetics (e.g., sunscreens, hair dyes, children's cosmetics) still require animal testing. The Provisions set more rigorous safety reference requirements for cosmetic ingredients. For new ingredients with records of safe use in foreign markets, or those approved by foreign regulatory authorities, certain toxicological test requirements may be waived based on the ingredient's risk level.
Notably, alternative methods to animal testing are selected for safety assessment, appropriate Integrated Approaches to Testing and Assessment (IATA) must be selected based on the ingredient's structural characteristics and specific endpoints. If the alternative method is not yet included in China's "Safety and Technical Standards for Cosmetics", it must be a method recognized by international authoritative alternative method validation organizations, accompanied by evidence of its accuracy in predicting the toxicological endpoint.
Under the new policy implemented in January 2024 by the NMPA, the filing process for non-high-risk new ingredients has been accelerated, and the responsibility for safety monitoring has shifted from the government to the registrant or filer, requiring them to submit annual safety monitoring reports during the three-year monitoring period, which may incorporate alternative methods recognized by international validation bodies or listed within China’s “Safety and Technical Standards for Cosmetics.” The emphasis on using Integrated Approaches to Testing and Assessment (IATA) seeks to ensure that safety assessments are both scientifically rigorous and tailored to the specific toxicological profiles of the ingredients involved.
China's regulatory landscape for animal testing is undergoing a profound transformation across the pharmaceutical, biotechnology, and cosmetic industries. Stakeholders’ embrace of alternative methods like organ-on-a-chip and organoids signals a pivotal shift towards more ethical, efficient, and human-relevant research practices.
https://english.nmpa.gov.cn/2024-06/07/c_994356.htm
https://course.cirs-group.com/cosmetics-and-disinfectants/298?l=en
https://www.eusmecentre.org.cn/publications/cosmetics-regulatory-roadmap-navigating-csar-updates-full-safety-assessments/
The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.
