Regulatory Affairs Professionals Society 83 Premarket Requirements/ Dossier Requirements Updated by Monique Carter, MS, RAC, and Jesshanie Tabaniag Chapter 8 OBJECTIVES ‰ ‰ Understand medicinal products’ premarket requirements ‰ ‰ Describe the Common Technology Document (CTD) triangle ‰ ‰ Describe the individual CTD module requirements ‰ ‰ Understand aspects to consider in compiling an effective application ‰ ‰ Understand the different application types REGULATIONS AND GUIDANCES COVERED IN THIS CHAPTER ‰ ‰ International Council for Harmonisation (ICH) ű ű M4 (R4): Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (15 June 2016) ű ű M4Q (R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use-Quality Overall Summary of Module 2 Module 3: Quality (12 September 2002) ű ű M4S (R2): The Common Technical Document for the Registration of Pharmaceuticals for Human Use-Nonclinical Overview and Nonclinical Summaries of Module 2, Organisation of Module 4 (20 December 2002) ű ű M4E (R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy-Clinical Overview and Clinical Summaries of Module 2, Module 5 Clinical Study Reports (15 June 2016) ű ű Q3A(R2): Impurities in New Drug Substances (25 October 2006) ű ű Q3B(R2): Impurities in New Drug Products (2 June 2006) ű ű Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (6 October 1999) ű ű Q6B: Specification: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products (10 March 1999) ű ű Certification of Suitability to the Monograph of European Pharmacopoeia (CEP) ű űű Q8(R2): Pharmaceutical Development ű S7A: Safety Pharmacology Studies for Human Pharmaceuticals
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