DEUTSCH / ENGLISH
RICHTLINIEN
European Medicines Agency:
Virusvalidierungs- und Prionenevaluierungs-Studies
- Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. – February 1996
- Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk. – October 2004
Plasmaderivate
- Guideline on plasma-derived medicinal products. – July 2011
- Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal product [Position statement]. – June 2011
- Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk. – October 2004
- West Nile virus and plasma-derived medicinal products [Position statement]. – July 2003
- Viral safety of plasma-derived medicinal products with respect to hepatitis E virus [Reflection paper]. – June 2016
- Warning on transmissible agents in SPCs for plasma derived medicinal products. – December 2011
Plasma Master File
- Scientific data requirements for plasma master file. – November 2006
- Epidemiological data on blood transmissible infections. – March 2016
- Non-renumerated and renumerated donors: safety and supply of plasma-derived medicinal products [Position statement]. – May 2002
Produkte aus Zellkulturen
- Quality of Biotechnological Products: Viral safety Evaluation – ICH Q5A. – October 1997
- Use of bovine serum in the manufacture of human biological medicinal products. – May 2013
- Use of porcine trypsin used in the manufacture of human biological medicinal products. – February 2014
Advanced Therapy
- Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products. – November 2008 (currently under revision)
- Quality, preclinical and clinical aspects of gene therapy medicinal products. – April 2001 (currently under revision)
- Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. – May 2012 (currently under revision)
- Development and manufacture of lentiviral vectors. – May 2005
- Non-clinical studies required before first clinical use of gene therapy medicinal products. – May 2008
- Non-clinical testing for inadvertent germline transmission of gene transfer vectors. – November 2006
- Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products. – February 2013
- Follow-up of patients administered with gene therapy medicinal products. – November 2009
- Scientific requirements for the environmental risk assessment of gene-therapy medicinal products. – May 2008
- Design modifications of gene therapy medicinal products during development [Reflection Paper]. – February 2012
- Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors [Reflection Paper]. – July 2010
- ICH Considerations: general principles to address virus and vector shedding. – July 2009
- ICH Considerations: oncolytic viruses. – October 2009
- Creutzfeldt-Jakob disease and advanced therapy medicinal products [Position statement]. – June 2011
- Human cell-based medicinal products. – May 2008
- Xenogeneic cell-based medicinal products. – November 2009
- In-vitro cultured chondrocyte containing products. – May 2010
- Stem cell-based medicinal products [Reflection paper]. – February 2011
- Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccine. – August 2010
Food and Drug Administration (FDA) in USA
Plasmaderivate
- Guidance for Industry: Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products. – December 2015
- 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. – December 2017
- Guidance for Industry: Nucleic acid testing (NAT) to reduce the possible risk of human parvovirus B19 transmission by plasma-derived products. – July 2009
- Guidance for Industry: Use of nucleic acid tests to reduce the risk of transmission of West Nile virus from donors of whole blood and blood components intended for transfusion. – November 2009
- Guidance for Industry: Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. – August 2016
- Guidance for Industry: 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
- Draft Guidance for Industry: Amendment to „Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood products; Guidance for Industry“. December 2017
Produkte aus Zellkulturen
Advanced Therapy Medicinal Products
- Guidance for Industry: Preclinical assessment of invetigational cellular and gene therapy products. – November 2013
- Guidance for Industry: Design and analysis of shedding studies for virus or bacteria-based gene therapy and oncolytic products. – August 2015
- Guidance for Industry: Use of nucleic acid tests to reduce the risk of transmission of hepatitis B virus from donors of human cells, tissues, and cellular and tissue-based products. – August 2016
- Guidance to Industry: Donor screening recommendations to reduce the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products. May 2018
- Guidance for Industry: Use of nucleic acid tests to reduce the risk of transmission of West Nile virus from living donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). – May 2017
- Guidance for Industry: Recommendations for microbial vectors used for gene therapy. – September 2016
- Guidance for Industry: Revised recommendations for determining eligibility of donors of human cells, tissues, and cellular and tissue-based products who have received human-derived clotting factor concentrates. – November 2016
- Guidance for Industry: Source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans. – December 2016