DEUTSCH / ENGLISH

GUIDELINES

European Medicines Agency:

Virus validation and prion evaluation 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
  

Plasma derivatives

• 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
  

Cell culture derived products

• 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

Plasma derivatives (and blood / blood components for transfusion)

• 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
  

Cell culture derived products

• Guidance for Industry: Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications. – February 2010
  

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