ICH Q8: Pharmaceutical Development. Regulatory Requirements Directed by the New Note for Guidance (EMEA/CHMP/167068/2004) in Comparison to the Previous Guideline (CPMP/QWP/155/96). A Critical View from the Generic Pharmaceutical Industry

List of abbreviations 4 Introduction 5 The history and development of the new guideline ICH Topic Q8 5 The contents and requirements according to the new guideline 9 Comparison of the current guideline ICH Q8 with the previous guideline 15 Comparison of both guidelines – a summary 28 The term Design Space-Integration into ICH Q8, Q9 and Q10 29 Requirements of the new guideline for the innovating pharmaceutical industry 33 Requirements of the new guideline for the generic pharmaceutical industry 34 General considerations 35 Development of a generic pharmaceutical product 37 Requirements to generic pharmaceutical development according to the new guideline 40 Critical discussion of the new guideline from the viewpoint of the generic pharmaceutical industry 43 Summary and outlook 47 References 49 4 5 Introduction In November 2005 the new " Note for Guidance on Pharmaceutical Development " (EMEA/CHMP/167068/2004) was approved by the EMEA (European Medicines Agency) and came into operation on 1 May 2006. This guideline follows the previous " Note for Guidance on Development Pharmaceutics " (CPMP/QWP/155/96) from July 1998 although this has not explicitly been mentioned in the new guideline[1, 2]. The new guideline is the transition by the CHMP (Committee for Human Medicinal Products within the EMEA) of the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Topic Q8 (Q = quality) with the identical title " Pharmaceutical Development " , which was finalised (Step 4) in November 2005 [3]. The Pharmaceutical Development section in the quality Module 3 itself provides a summary and overview of the components of the drug product, its manufacture and quality control with the special focus on the development aspects of the drug product from early initial galenical stages towards a high qualitative product as intended for the market. The aim of this thesis is to compare the requirements as presented by the new guideline (EMEA/CHMP/167068/2004) in comparison to the ones directed by the previous guideline (CPMP/QWP/155/96). A special focus is laid on the needs and requirements for the generic pharmaceutical industry with respect to pharmaceutical development and a reflection of its conversion in the near future. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the …