1 The Aims and Structure of Regulations<br>1.1 Introduction<br>1.2 Purpose and Principles of Regulation<br>1.3 The Legal Framework for Regulation<br>1.4 Basic Legislation<br>1.5 Scope of the Legislation<br>1.6 Chapter Review<br>1.7 Further Reading<br>2 Regulatory Strategy<br>2.1 Chapter Introduction<br>2.2 Basic Regulatory Strategy<br>2.3 Quality Assurance Systems<br>2.4 Validation<br>2.5 Regulatory Bodies<br>2.6 International Harmonisation Bodies<br>2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use<br>2.8 Pharmaceutical Inspection Cooperation Scheme (PICS)<br>2.9 The World Health Organization (WHO)<br>2.10 Chapter Review<br>2.11 Further Reading<br>3 Drug Discovery Classification and Early Stage Development<br>3.1 Chapter Introduction<br>3.2 Drug Categorisation<br>3.3 Drug Discovery<br>3.4 Drug Development<br>3.5 Drug Delivery<br>3.6 Chapter Review<br>3.7 Suggested Reading<br>4 Non-Clinical Studies<br>4.1 Chapter Introduction<br>4.2 Non-Clinical Study Objectives and Timing<br>4.3 Pharmacological Studies<br>4.4 Bioavailability and Bioequivalence<br>4.5 Toxicology Studies<br>4.6 Chemistry, Manufacturing and Control Development<br>(CMC)<br>4.7 Quality by Design<br>4.8 Quality of Biotech Products<br>4.9 Good Laboratory Practice (GLP)<br>4.10 Chapter Review<br>4.11 Further Reading<br>5 Clinical Trials<br>5.1 Chapter Introduction<br>5.2 Clinical Trials<br>5.3 Clinical Trial Design<br>5.4 Good Clinical Practice<br>5.5 Clinical Trials in the EU<br>5.6 Clinical Trials in The US<br>5.7 Chapter Review<br>5.8 Further Reading<br>6 Marketing Authorisation<br>6.1 Chapter Introduction<br>6.2 The Application Dossier<br>6.3 CTD<br>6.4 Submission and Review Process in the EU<br>6.5 Submission and Review Process in the US<br>6.6 Chapter Review<br>6.7 Further Reading<br>7 Authorisation of Veterinary Medicines<br>7.1 Chapter Introduction<br>7.2 Overview of Development Process for Veterinary<br>Medicines<br>7.3 Authorisation of Clinical Trials in the EU<br>7.4 Authorisation of Clinical Trials in the US<br>7.5 Maximum Residue Limits (MRLs)<br>7.6 Authorisation of Veterinary Medicines in the EU<br>7.7 Approval of Veterinary Medicines in the US<br>7.8 Chapter Review<br>7.9 Further Reading<br>8 Variations to the Drug Authorisation Process<br>8.1 Chapter Introduction<br>8.2 Provisions in Support of Special Drug Applications<br>8.3 Accelerated Access to New Drug Therapies<br>8.4 Approval of New Drugs when Human Efficacy Studies are<br>not Ethical or Feasible<br>8.5 Animal Drugs for Minor Use and Minor Species<br>8.6 Use of Non-Authorised Drugs for Animal Treatment in the EU<br>8.7 Changes to an Authorised Drug<br>8.8 EU System for Processing Changes<br>8.9 Processing Changes in the US<br>8.10 Authorisation of Generic Drugs<br>8.11 Reference Drug Exclusivity<br>8.12 Other Authorisation Procedures<br>8.13 Chapter Review<br>8.14 Further Reading<br>9 Medical Devices<br>9.1 Chapter Introduction<br>9.2 Regulatory Strategy for Medical Devices in the EU<br>9.3 Regulatory Strategy for Medical Devices in the US<br>9.4 Development of Devices<br>9.5 Chapter Review<br>9.6 Further Reading<br>10 Authorisation of Medical Devices<br>10.1 Chapter Introduction<br>10.2 Evaluation of Medical Devices in Europe<br>10.3 Evaluation of Medical Devices in the US<br>10.4 Placing of Devices on the Market in the EU<br>10.5 Placing of Devices on the Market in the US<br>10.6 Chapter Review<br>10.7 Further Reading<br>11 Good Manufacturing Practice (GMP)<br>11.1 Chapter Introduction<br>11.2 Drug GMP Regulations and Guidance<br>11.3 Essential GMP Requirements<br>11.4 Validation<br>11.5 GMP Requirements for Devices<br>11.6 Chapter Review<br>11.7 Further Reading<br>