chapter 1 Introduction and history of pharmaceutical regulation / Anthony C. Cartwright
chapter 2 The European Community: its structure, institutions, and regulation / Anthony C. Cartwright
chapter 3 New chemical active substance products: quality requirements / Brian R. Matthews
chapter 4 New chemical active substance products: preclinical requirements / James C. Ritchie
chapter 5 New chemical active substance products: clinical requirements / J. Alex Nicholson
chapter 6 Abridged applications / Anthony C. Cartwright
chapter 7 Drug master files / Brian R. Matthews
chapter 8 Radiopharmaceutical products / Brian R. Matthews
chapter 9 Medicated devices / Brian R. Matthews
chapter 10 Contact lens products and intrauterine contraceptive devices / Brian R. Matthews
chapter 11 Experts and Expert Reports in marketing authorisation applications / Anthony C. Cartwright
chapter 12 Defects in applications-an analysis / David B. Jefferys Brian R. Matthews James C. Ritchie
chapter 13 CPMP and the Pharmaceutical Committee / Anthony C. Cartwright
chapter 14 CPMP multistate procedure / Anthony C. Cartwright
chapter 15 The concertation (high technology/ biotechnology) procedure / Anthony C. Cartwright
chapter 16 Regulatory strategy: the EC, EFTA, the PER scheme
chapter 17 The United Kingdom's system for licensing pharmaceutical products / Brian R. Matthews
chapter 18 The other national authorities in the EC / Anthony C. Cartwright
chapter 19 EEC guidelines-quality, safety, efficacy, and biotechnology / Anthony C. Cartwright
chapter 20 The new general Directive, immunologicals etc. Directives
chapter 21 The Single Market after 1992: new directions / Anthony C. Cartwright.