International Medicines Regulations

Section I Historical Development and Role of Regulations.- 1 The historical development of medicines regulations.- 2 Setting the scene — the role of regulation.- 3 An international comparison of medicines regulations.- Discussions points.- Section II Objectives and Achievements of Regulations.- 4 Objectives and achievements of regulations in West Germany.- 5 Objectives and achievements of regulations in West Germany.- 6 Objectives and achievements of medicines regulations in the BENELUX countries.- 7 Objectives and achievements of regulations in The Netherlands.- 8 Objectives and achievements of regulations in the UK.- 9 Objectives and achievements of medicines regulations in the UK.- 10 The Swedish medicines regulatory system — with some notes on the Scandinavian situation.- 11 Objectives and achievements of medicines regulations in the Nordic countries.- 12 Objectives and achievements of regulations in the USA.- 13 Objectives and achievements of regulations in the USA.- 14 Objectives and achievements of regulations in Japan.- 15 Objectives and achievements of regulations in developing countries.- Discussion points.- 16 Overview of objectives and achievements of medicines regulations.- Section III Future Perspectives of Regulations in Japan and the United States.- 17 Future perspectives of regulations in Japan.- 18 Future perspectives of regulations in the United States.- 19 Future perspectives of regulations — industry viewpoint.- Discussion points.- Section IV Future Perspectives of Regulations in the European Economic Community.- 20 The role of the CPMP in the EEC.- 21 Future perspectives of regulations — internal market by 1992?.- 22 Future perspectives of regulations — harmonization of data requirements.- 23 Future perspectives of regulations —national authorities’ relationship with the EEC.- 24 Future perspectives of regulations — the concept of a European medicines office.- 25 Mutual recognition or a central European office?.- Discussion points.- Final round table discussion.- Appendix 1 The future systems in Europe.- ABPI Steering Group for Europe.- Appendix 2 Memorandum on the future system for the authorization of medicinal products in the European.- Community.- Commission of the European Communities Memorandum.