State Council Introduces 2026 Regulations Governing Clinical Research of Biomedical New Technologies in China

The Chinese State Council has issued the Regulations on the Administration of Clinical Research and Clinical Translational Application of Biomedical New Technologies (“the Regulations”), which will take effect on May 1, 2026. The new framework is designed to standardise safety, efficacy, and ethical oversight for emerging biomedical technologies across the country.

Key Provisions

• Scope of “Biomedical New Technologies”
  The Regulations define clinical research of biomedical new technologies as activities that test safety and efficacy through:
  1. Direct manipulation of the human body.
  2. Manipulation of isolated cells, tissues, or organs followed by implantation or infusion.
  3. Manipulation of human germ cells, zygotes, or embryos with subsequent implantation.
  4. Additional methods specified by the State Council’s health department.
• Institutional Requirements
  Clinical research initiating institution must be a legally‑established entity within China.
  Clinical research institution must:
  1. Be a Class 3A medical institution.
  2. Maintain a qualified clinical research academic committee and ethics committee.
  3. Possess appropriate facilities, equipment, and qualified personnel.
  4. Have a management system ensuring research quality, safety, ethical compliance, and protection of subjects.
  5. Secure a stable, sufficient funding source.
• Collaborative Agreements & Record‑Keeping
  Initiating and conducting institutions must sign a written agreement outlining rights and obligations and jointly develop a research plan. Research institutions may also independently initiate studies. All records and original materials must be preserved for 30 years (perpetually if offspring are involved).
• Translational Application Process
  For technologies cleared for clinical translation, the initiating institution must submit an application and supporting documents to the State Council’s health department. Medical institutions wishing to implement approved translational applications must meet conditions set by the health department.
• Legal Accountability
  The Regulations outline the legal responsibilities of each party, ensuring accountability for compliance, safety, and ethical conduct throughout the research lifecycle.

Implications for the Life‑Science Ecosystem

• Accelerated Pathways – By establishing clear criteria and streamlined approval processes, the Regulations aim to shorten the time from bench to bedside for cutting‑edge therapies.
• Enhanced Oversight – Mandatory ethics committees and robust record‑keeping strengthen patient safety and data integrity.
• Global Alignment – The framework aligns China’s standards with international best practices, potentially boosting global collaboration and investment in Chinese biomedical research.-Fineline Info & Tech