International Medicines Regulations: A Forward Look to 1992

ISBN-13: 9789401068734 / Angielski / Miękka / 2011 / 288 str.

S. R. Walker; A. R. Griffin

Opis

As 1992 looms on the horizon and preparation is made for the completion of the internal market in Europe, the CMR realised the value of addressing some of the issues involved and defining the objectives and achievements of medicines regulations in a number of EEC countries in comparison with Japan and the USA. The overall aim was to use the lessons of past experience to determine the most appropriate way forward. The final debate focused on two possibilities for assessing and granting marketing authorisations for Europe, namely mutual recognition or a centrally organised European Med- icines Office. These two views were discussed in detail at both the workshop at the Ciba Foundation and the international symposium at the Royal College of Physicians. It is hoped that this sharing of ideas and the publication of the proceedings of this fifth CMR Workshop will have encouraged all concerned to continue the debate so that the final outcome will be the establishment of an efficient system in the community for the benefit of patients, the practising physician and the pharmaceutical industry. We would like to take this opportunity of thanking Brenda Mullinger for the considerable amount of scientific and editorial work that she carried out on the manuscripts, Sheila Wright for providing the secretarial support which allowed the proceedings to be submitted to Kluwer Academic Publishers on disk and Sandra Cox who organised the administrative aspects so vital to the successful running of a Workshop and major international symposium. S. R.

Spis treści

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.