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