International medicines regulations : a forward look to 1992 : proceedings of the Centre for Medicines Research Workshop held at the CIBA Foundation, London, 20th/21st September 1988

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. Front Matter....Pages i-xiv Front Matter....Pages 1-1 The historical development of medicines regulations....Pages 3-18 Setting the scene — the role of regulation....Pages 19-26 An international comparison of medicines regulations....Pages 27-34 Back Matter....Pages 35-35 Front Matter....Pages 37-37 Objectives and achievements of regulations in West Germany....Pages 39-46 Objectives and achievements of regulations in West Germany....Pages 47-58 Objectives and achievements of medicines regulations in the BENELUX countries....Pages 59-66 Objectives and achievements of regulations in The Netherlands....Pages 67-72 Objectives and achievements of regulations in the UK....Pages 73-92 Objectives and achievements of medicines regulation in the UK....Pages 93-100 The Swedish medicines regulatory system — with some notes on the Scandinavian situation....Pages 101-110 The objectives and achievements of medicines regulations in the Nordic countries....Pages 111-116 Objectives and achievements of regulations in the USA....Pages 117-124 Objectives and achievements of regulations in the USA....Pages 125-134 Objectives and achievements of regulations in Japan....Pages 135-148 Objectives and achievements of regulations in developing countries....Pages 149-162 Back Matter....Pages 163-165 Overview of objectives and achievements of medicines regulations....Pages 167-170 Front Matter....Pages 171-171 Future perspectives of regulations in Japan....Pages 173-184 Future perspectives of regulations in the United States....Pages 185-194 Future perspectives of regulations — industry viewpoint....Pages 195-202 Back Matter....Pages 203-203 Front Matter....Pages 205-205 The role of the CPMP in the EEC....Pages 207-218 Back Matter....Pages 265-270 Front Matter....Pages 205-205 Future perspectives of regulations — internal market by 1992?....Pages 219-234 Future perspectives of regulations — harmonization of data requirements....Pages 235-242 Future perspectives of regulations — national authorities’ relationship with the EEC....Pages 243-248 Future perspectives of regulations — the concept of a European medicines office....Pages 249-260 Mutual recognition or a central European office?....Pages 261-264 Back Matter....Pages 265-270 Back Matter....Pages 271-312 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 MedƯ 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