Regulatory Library

Regulatory Agencies

• FDA
• The Code of Federal Regulations (CFR)
• EMA
• MHRA

General

• ICH
• ICH Topic Q5C,Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, CPMP/ICH/138/95, 1996
• ICH Topic Q6B, ICH Harmonized Tripartite Guideline, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, CPMP/ICH/365/96, 1999
• ICH Topic Q2(R1), ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology
• Points to consider in the manufacture and testing of therapeutic products for human use derived from transgenic animals, FDA, 1995
• Points to consider in the manufacture and testing of monoclonal antibody products for human use, FDA, 1997
• Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier, EMEA/CVMP/1069/02, 2005
• ICH Topic Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2001
• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics, FDA 2015

Potency

• EP 5.3 Statistical Analysis of Bioassays
• USP <1032> Design and Development of Biological assays, USP, 2010
• USP <1033> Biological Assay Validation, USP, 2010
• USP <1034> Analysis of Biological Assays, USP, 2010 

Potency of Cell Therapy Products

• Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, FDA, 2011

Pharmacokinetics

• Guidance for Industry:  Bioanalytical Method Validation, FDA,  2001
• Guideline on bioanalytical method validation, EMEA/CHMP/EWP/192217/2009, 2011 
• Guidance for Industry: Bioanalytical Method Validation, FDA, 2018Bioanalytical Method Validation, FDA, 2018 

Immunogenicity

• Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutics Proteins, EMEA/CHMP/BMWP/14327/2006, 2007
• Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, FDA, 2009
• Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for in vivo Clinical Use, EMA/CHMP/BMWP/86289/2010, 2012
• Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products, FDA, 2013
• Guideline on Immunogenicity assessment of Therapeutic Proteins, EMEA/CHMP/BMWP/14327/2006 Rev 1, 2017
• Guidance for Industry: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, FDA, 2019

Biosimilars

• Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substances: Quality Issues, EMEA/CHMP/BWP/49348/2005, 2006
• Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance:Quality Issues (revision 1), Draft. Once finalized will replace EMEA/CHMP/BWP/49348/2005
• Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies – Non-clinical and Clinical Issues, EMA/CHMP/BMWP/403543/2010, 2012
• Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, FDA Draft Guidance, 2012
• Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, FDA Draft Guidance, 2012
• Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, FDA Draft Guidance, 2012

• Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, FDA Draft Guidance, 2013

• Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, FDA Draft Guidance, 2014

• Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act, FDA Draft Guidance, 2014

• Guidance for Industry: Considerations in Demonstrating Interchangeability with a Reference Product, FDA Draft Guidance, 2017