Biologics Regulatory Document Library

EMA

• Guideline on Similar Biological Medicinal Products (2014)
• Guideline on Similar Biological Medicinal Products Containing Interferon Beta (2013)
• Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Human Follicle Stimulating Hormone (r-hFSH) (2013)
• Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products (2011)
• Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (2013)
• Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Clinical and Non-Clinical Issues (2011)
• Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (2011)
• Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies (2010)
• Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (Revision 1) (2014)
• Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (2003)

OJEC

• Directive 2004/27/EC Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use (2004)

• Draft Guidance for Industry: Nonproprietary Naming of Biological Products (August 2015)
• Draft Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (2013)
• Draft Guidance for Industry: Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (2012)
• Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (2015)
• Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (2015)
• Guidance for Industry: M4S: The CTD—Safety (2001)
• Guidance for Industry: M4S: The CTD—Safety Appendices (2001)

• Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products (1999)

• Guidelines for the Quality, Safety and Effectiveness of Biosimilar Products (2009)
  バイオ後続品の品質・安全性・有効性確保のための指針

• Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) (2009)

• EP 2.6.1 - Sterility
• EP 2.6.8 - Pyrogens
• EP 2.6.9 - Abnormal Toxicity
• EP 2.6.14 - Bacterial Endotoxins

FDA

• Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (2004)
• Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation (1997)
• Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV (2004)
• Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (2002)
• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (2007)
• Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (2001)
• PHS Guidelines on Infectious Disease Issues in Xenotransplantation (2001)
• Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection (2005)
• Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (2002)
• Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers (2012)

USP*

• USP<71> Sterility Tests
• USP<85> Bacterial Endotoxins Test
• USP<88> Biological Reactivity Tests, In vivo
• USP<151> Pyrogen Test

• ISO 11737-1: Sterilization of Medical Devices Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products
• ISO 11737-2: Sterilization of Medical Devices Microbiological Methods - Part 2: Tests of Sterility performed in the Definition, Validation, and Maintenance of a Sterilization Process

• Notification of the Guideline for Securing Viral Safety of Plasma Derived Products (1999)
  血漿分画製剤のウイルスに対する安全性確保に関するガイドライン
• Standards for Biological Ingredients
  生物由来原料基準

EMA

• Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (2009)

EP*

• EP 5.2.3 - Cell Substrates for Production of Vaccines for Human Use