美国监管部门关于基因与细胞治疗产品的相关法规和指导原则汇总-20220316update-药研库

本文主要目的是跟踪美国对于CGT产品法规和指导原则等政策文件，长期更新。

1998.03 Guidance for Industry: Guidance for Human Somatic Cell Therapy GeneTherapy FDA
2001.02 Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based GeneTherapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors FDA
2006.11 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector-Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors FDA
2006.11 Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events FDA
2007.08 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products FDA
2008.04 Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control(CMC) Information for Human Somatic Cell Therapy Investigation New Drug Applications(INDs) FDA
2009.09 Considerations for Allogeneic Pancreatic Islet Cell Products FDA
2010.02 Characterization and Qualification of Cell Substrates and other Biological Materials Used in the Production of Viral Vaccines for infectious Disease indications FDA
2010.1 Cellular therapy for Cardiac Disease FDA
2011.01 Potency tests for Cellular and gene Therapy Products FDA
2011.1 Clinical Considerations for Therapeutic Cancer Vaccines FDA
2011.12 Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)-Guidance for Industry FDA
2012.11 Guidance for Industry: Potency Tests for Investigational Cellular and Gene Therapy Products FDA
2011 USP General Chapter<1046>,”Cell and Gene Therapy Products USP
2013.11 Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Guidance for Industry FDA
2014.03 BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System FDA
2015.03 Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry FDA
2015.06 Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry FDA
2015.08 Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry FDA
2017.09 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 FDA
2017.11 Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception FDA
2018.07 Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft guidance for industry FDA
2018.07 Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry FDA
2018.07 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry FDA
2018.07 Human Gene Therapy for Rare Diseases; Draft Guidance for Industry FDA
2019.02 Guidance for Industry:Evaluation of Devices Used with Regenerative Medicine Advanced Therapies FDA
2019.02 Guidance for Industry:Expedited Programs for Regenerative Medicine Therapies for Serious Conditions FDA
2020.01 Human Gene Therapy for Retinal Disorders FDA
2020.01 Human Gene Therapy for Rare Diseases FDA
2020.01 Human Gene Therapy for Hemophilia FDA
2020.02 Guidance for Industry:Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) FDA
2020.02 Guidance for Industry:Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up FDA
2020.02 Guidance for Industry:Long Term Follow-up After Administration of Human Gene Therapy Products FDA
2020.07 Guidance for Industry and Food and Drug Administration Staff:Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use FDA
2021.01 Human Gene Therapy for Neurodegenerative Diseases:Draft Guidance for Industry FDA
2021.01 Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health EmergencyGuidance for Industry FDA
2021.09 Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical TrialDraft Guidance for Industry FDA
2021.12 Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals FDA