To All Relevant Units:

Recently, the National Health Commission (NHC) issued the *Guidelines for the Filing of Clinical Research on New Biomedical Technologies*. Serving as the implementing rules for the *Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies* (hereinafter referred to as the "Regulation 818") promulgated by the State Council, these guidelines formally establish the regulatory pathways and translational mechanisms for Investigator-Initiated Trials (IITs). This marks a significant step—one characterized by systematization and adherence to the rule of law—in my country's governance of cutting-edge technologies such as stem cells, gene editing, CAR-T therapy, and exosomes.

IITs involving cell therapies represent a unique form of clinical research specific to my country's cell therapy landscape. Under the administrative purview of the NHC, these trials differ significantly—across various aspects ranging from regulatory oversight and filing/approval procedures to actual clinical implementation—from Investigator-Sponsored Trials (ISTs), which fall under the jurisdiction of the National Medical Products Administration (NMPA). In addition to Regulation 818, the NHC has issued a series of targeted policies—including the *Guidelines for Clinical Research on Somatic Cells* and the *Administrative Measures for Clinical Research on Stem Cells*—that elucidate both the general considerations for conducting IITs involving such products and the specific considerations applicable to individualized therapeutic products.

To assist pharmaceutical enterprises in navigating the policy changes associated with Regulation 818, we have invited industry experts to provide a systematic overview—encompassing both theoretical principles and practical applications—of the entire lifecycle requirements for cell therapy product IITs: from initial filing through clinical research to translational application. This comprehensive session will cover relevant policy details, regulatory standards, operational workflows, and risk assessment methodologies. The objective is to enhance participants' professional knowledge and technical proficiency regarding clinical trials for cell therapy products, thereby providing support and assistance to pharmaceutical enterprises as they strive to achieve breakthroughs and foster innovation within the field of cell therapy IITs. The detailed notice is as follows:

Course Schedule

Date: April 25–26, 2026

Location: Live Online Broadcast

Key Conference Topics and Speakers

Day One

(I) Regulation 818 and my country’s IIT Regulations

1. Regulatory Framework and Governing Bodies for IIT Clinical Research in my country

2. Relevant Regulations and Management Models for IITs in my country

3. Regulation 818 and the *Guidelines for the Filing of Clinical Research on New Biomedical Technologies*

4. Criteria for Identifying New Biomedical Technologies, Categorization Lists, and Filing Guidelines

5. Other IIT-Related Regulations: *Guidelines for Clinical Research on Somatic Cells*, *Measures for the Administration of Clinical Research and Translational Application of Somatic Cell Therapy*, *Measures for the Administration of Clinical Research on Stem Cells*, and *Measures for the Administration of Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions*

6. Regulatory Trajectories and Evolving Trends in my country’s Cell Therapy IIT Regulations

7. Collaborative Synergy and Division of Authority between the National Health Commission (NHC) and the National Medical Products Administration (NMPA)

(II) Comparison of Domestic and International IIT Regulatory Frameworks

1. Historical Evolution of IIT Clinical Regulations and Policies in Europe and the U.S.

2. IITs in the U.S.: Early-Phase Trials and Expanded Access Programs

3. EU Requirements for IITs Involving ATMPs (Advanced Therapy Medicinal Products) and Hospital Exemptions Exemption)

4. How IITs Are Funded Internationally

5. The Impact of International IIT Practices on Domestic Policymaking

(III) Clinical Research and NHC Filing

1. Required Materials and Procedures for NHC Filing: CTRI Platform Registration, Prior Ethics Review, and Investigator Qualification Requirements

2. Responsibilities of Medical Institutions in IIT Clinical Trials: Investigators, Ethics Committees, and GCP-Certified Institutions

3. Joint Filing and Filing for Lead Centers in Multi-Center Clinical Trials

4. Similarities and Differences in Filing Procedures for Stem Cells vs. Somatic Cells

5. Non-Clinical Studies Required for IIT Filing

6. Informed Consent and Patient Protection

7. Funding Sources for IIT Clinical Research

8. Common Reasons for Filing Rejection and Corresponding Counter-Strategies

(IV) Clinical Translation and Pricing

1. The Dual-Track System for Pharmaceuticals and Medical Technologies

2. Standards for the Translational Application of Medical Technologies Under NHC Regulation

3. Requirements and Required Materials for Applying for Translational Application

4. Common Models for Translational Application: In-House Preparations, Hospital-Developed Reagents, "Front-Clinic, Back-Factory" Models, and Compassionate Use

5. Translational Application in "Pilot Zones" for Medical Innovation: Bo'ao, Nansha, and Beidaihe

6. Costs and Pricing in Technology Translation

7. Academic Publication and Industry Sharing

8. Potential Legal Disputes and Ethical Considerations in the Translational Application of Medical Technologies

9. Risks Associated with Patenting Medical Technologies

10. The Transition of IIT Clinical Data to Regulatory Clinical Trials

Day Two

(V) Establishing a Quality System for Preparations

1. Major Challenges for Hospitals Conducting Independent IITs

2. Key Considerations for Establishing a Quality Management System (QMS) Under the "August 18" New Regulations

3. The "Qualified Person" System: A Holistic Research Approach Spanning "Process – Quality – Clinical"

4. Basic Requirements for Facilities and Equipment

5. Manufacturing Process and Product Quality Control

6. Mandatory Quality Control Items and Standard Limits

7. Third-Party Contract Testing

8. Deviation Management and CAPA

9. Quality Requirements for Ancillary Products (Plasmids, Viral Vectors, etc.)

10. Varying Quality Requirements Across Clinical Research and Translational Application Stages

(VI) Non-Clinical Studies

1. General Requirements for Non-Clinical Studies of Cell Therapies

2. List of Non-Clinical Experiments Required for IIT Filing

3. Tumorigenicity and Oncogenicity

4. Target-Related Toxicity and Off-Target Effects

5. Immunogenicity and Immunotoxicity

6. Animal Studies: Efficacy, PK, and Toxicology

7. Exemption from Non-Clinical Studies Based on Existing Clinical Data

(VII) Clinical Design and Operations

1. Classification and Characteristics of Cell Therapy Products

2. Scientific Positioning of IIT Studies: Exploratory, Bridging, and Confirmatory

3. Clinical Trial Protocol Design: Single-Arm, Cohort, and Randomized Controlled Trials

4. Indication Selection and Subject Stratification

5. Starting Dose and Preconditioning Regimens

6. Selection of Endpoints: Efficacy, Safety, and Exploratory Endpoints

7. PK and PD Study Methodologies

8. Safety Events and Clinical Risk Management: AE Grading, Emergency Response Procedures, SAE Reporting, and Long-Term Follow-up

9. Data Management and Statistical Analysis

10. Common Issues in IIT Implementation: Site Initiation, Patient Enrollment, Facility Audits, Manufacturing-Clinical Linkage, and Study Summarization

11. Current Status and Common Challenges in IIT Clinical Research

(VIII) Scientific Innovation in IIT Clinical Research

1. Identifying Unmet Clinical Needs for Cell Therapy Products

2. Key Strategies and Considerations for Solid Tumor Treatment

3. IIT Clinical Studies for Allogeneic (Off-the-Shelf) Cell Therapy Products

4. IIT Clinical Studies for In Vivo CAR-T Therapies

5. Novel Cell Product Types: NK, Macrophages, NKT, Neutrophils, and ILCs

6. Combination Therapy with Anti-Tumor Agents

7. Hospital-Based Manufacturing: "Vein-to-Vein" and "Place-of-Care" Models

8. Indication Expansion: Autoimmune Diseases, Infectious Diseases, and Cardiovascular/Cerebrovascular Diseases

9. Selecting Clinical Research Directions Aligned with Product-Specific Characteristics

Instructor: Dr. Zhang Changfeng. Dr. Zhang serves as the Director of Regulatory Affairs and Quality for Biotherapeutics at Shanghai Pharmaceuticals Holding Co., Ltd. A former student of Academician Carl June—widely recognized as the "Father of CAR-T"—he played a pivotal role in the FDA regulatory submission process for products such as Kymriah (the world's first approved CAR-T therapy). Upon returning to China, he served as the lead executive responsible for securing the country's first Investigational New Drug (IND) approval for a gene-edited CAR-T product. Furthermore, he has co-organized numerous U.S.-China policy seminars on cell therapy in collaboration with key regulatory bodies, including the Center for Drug Evaluation (CDE) and the National Institutes for Food and Drug Control (NIFDC). To date, Dr. Zhang has authored and published multiple papers in prestigious international journals—including *Nature Medicine*, *Blood*, and *JCI Insight*—and has spearheaded numerous clinical studies, providing treatment to over 1,000 patients suffering from various cancers, such as leukemia and myeloma.

Conference Fees

Conference Fee: ¥4,000 per organization (The fee covers: training sessions, seminars, digital course materials, digital training certificates, and one year of video replay access). (To help organizations minimize learning costs and facilitate work scheduling, the sessions may be projected for group viewing by all employees, in addition to the one-year video replay access.)

Training Certificates

Upon the conclusion of the training, participants may log in to the Association's official website system to view or download their training certificates.