The General Office of the National Health Commission issued the Letter of Opinion on “Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim)

Chapter 1 General Provisions

Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations on the Administration of Medical Institutions and other laws and regulations to meet clinical needs, standardize and promote clinical research and transformational application of somatic cell therapy.

Article 2 Somatic cell therapy refers to a treatment method in which somatic cells derived from human autologous or allogeneic sources are returned (or implanted) into the human body after in vitro manipulation. Such in vitro manipulation includes in vitro activation, induction, amplification, passage and screening of cells, as well as treatment with drugs or other substances that can change the biological functions of cells.

Article 3 These Measures apply to clinical research and transformational application of somatic cell therapy developed, prepared and carried out by medical institutions in the medical institutions.

The catalog of somatic cell therapy transformational application projects managed in accordance with these Measures shall be formulated and dynamically managed by the National Health Commission.

Article 4 Medical institutions conducting clinical research and transformational application of somatic cell therapy and their clinical research projects and transformational application projects shall meet the corresponding conditions, be registered with the National Health Commission, and carry out clinical research and transformational application of somatic cell therapy within the scope of the registered projects.

Article 5 Medical institutions are responsible for the clinical research and translational application of somatic cell therapy and are responsible for the quality of somatic cell preparation.

Article 6 The National Health Commission is responsible for the management of clinical research and translational application of somatic cell therapy, organizes the formulation and release of the "Technical Specifications for Clinical Research and Translational Application of Somatic Cell Therapy" in reference to the core technical standards of the Good Manufacturing Practice for Pharmaceuticals, establishes a somatic cell therapy expert committee, provides technical support and ethical guidance for the standardized management of clinical research and translational application of somatic cell therapy, and establishes and maintains the registration and filing information system for clinical research and translational application of somatic cell therapy (hereinafter referred to as the filing information system).

Article 7 The National Health Commission is responsible for supervising and inspecting medical institutions registered for clinical research and translational application of somatic cell therapy, and provincial health administrative departments are responsible for the daily supervision and management of registered medical institutions within their administrative regions. When problems and risks are found, they will promptly urge medical institutions to take effective measures and report to the National Health Commission.

Specific news link: Letter from the General Office of the National Health Commission on Soliciting Opinions on the Administrative Measures for Clinical Research and Transformation Application of Somatic Cell Therapy (Trial) (Draft for Comments)