Regulatory Guidelines

Regulatory Guidelines2018-11-24T14:10:06+00:00
Over the years, regulatory agencies world-wide have issued various guidelines and point-to-consider for biological identity and safety tests. To assist our clients to better understand regulatory requirements, we have compiled a series of documents from US FDA, ICH, and WHO.

Cell Bank Characterization

Gene therapy

  • EMEA_2009_Gene_Therapy TITLE: Questions and Answers on Gene Therapy
  • FDA_1998_GFI_Somcell TITLE: Guidance for Human Somatic Cell Therapy and Gene Therapy
  • FDA_2008_GFI_Somcell TITLE: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

In Vivo Diagnostic Device

  • FDA_1989_PTC_HIV TITLE: Draft of “Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type 1 (1989)”
  • FDA_1999_GFI_HIV TITLE: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
  • FDA_2011_GFI_Influenza TITLE: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses

mAb Antibody

  • FDA_1997_PTC_mAb TITLE: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Pharmacogenetic and Genetic Tests

Recombinant DNA

  • FDA_1983_PTC_rDNA TITLE: Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technolog
  • FDA_1985_PTC_rDNA TITLE: Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
  • FDA_1992_PTC_rDNA TITLE: Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologic& Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability
  • FDA_1996_GFI_rDNA_mAb TITLE: FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE
  • ICH_1996_Q5B_rDNA TITLE: ICHTopic Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products

Vaccine

Viral Safety

  • EMEA_2006_Viral_Safety TITLE: GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
  • ICH_1997_Viral_Safety TITLE: VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN
  • ICH_1998_Q5A_Viral_Safety TITLE: Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin

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