Module 9 2021

19/03/2021

Cell and Gene Therapy Regulatory Guidance

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European Guidance

a. CPMP/BWP/3088/99 Note For Guidance on the Quality, Preclinical, and Clinical Aspects of Gene Transfer Medicinal Products (October 2001) b. EMA/CHMP/GTWP/BWP/234523/2009 Concept Paper on the Revision of the Note for Guidance on the Quality, Pre-Clinical and Clinical Aspects of Gene Transfer Medicinal Products (End of Consultation Period March 2010) c. Draft Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (Deadline for Comments Aug 2015) d. USA (FDA) Guidance e. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (CBER August 2007) f. Guidance for Human Somatic Cell Therapy and Gene Therapy (March 1998) g. Guidance for Industry: 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 (November 2006) h. Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry (March 2015) i. Recommendations for Microbial Vectors used for Gene Therapy (September 2016) j. EudraLex: The Rules Governing Medicinal Products in the European Union Volume Good Manufacturing Practice: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products 22- Nov-2017

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The picture can't be displayed. Blood Products Guidance 1. European Guidance a. WHO Technical Report, Series No. 924, 2004 Annex 4: Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products 2. USA (FDA) Guidance a. CBER Guidance for Industry Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components August 2016. b. CBER Guidance for Industry Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus January 2017 c. CBER Guidance for Industry Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use – Compliance Policy August 2016 d. Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products January 2016 e. CBER Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus October 2012 f. CBER Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry May 2010 g. CBER Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products July 2009

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