International Medicines Regulations

1. Front Matter

   Pages i-xiv

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2. Historical Development and Role of Regulations

   1. Front Matter

      Pages 1-1

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   2. The historical development of medicines regulations

      • R. D. Mann

      Pages 3-18

   3. Setting the scene — the role of regulation

      • L. Lasagna

      Pages 19-26

   4. An international comparison of medicines regulations

      • M. N. G. Dukes

      Pages 27-34

3. Back Matter

   Pages 35-35

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4. Objectives and Achievements of Regulations

   1. Front Matter

      Pages 37-37

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   2. Objectives and achievements of regulations in West Germany

      • G. Lewandowski

      Pages 39-46

   3. Objectives and achievements of regulations in West Germany

      • R. Bass

      Pages 47-58

   4. Objectives and achievements of medicines regulations in the BENELUX countries

      • P. Claessens, J. Muschart

      Pages 59-66

   5. Objectives and achievements of regulations in The Netherlands

      • C. A. Teijgeler

      Pages 67-72

   6. Objectives and achievements of regulations in the UK

      • J. P. Griffin

      Pages 73-92

   7. Objectives and achievements of medicines regulation in the UK

      • M. D. Rawlins

      Pages 93-100

   8. The Swedish medicines regulatory system — with some notes on the Scandinavian situation

      • L. E. Böttiger

      Pages 101-110

   9. The objectives and achievements of medicines regulations in the Nordic countries

      • J. Idänpään-Heikkilä

      Pages 111-116

   10. Objectives and achievements of regulations in the USA

       • J. R. Crout

       Pages 117-124

   11. Objectives and achievements of regulations in the USA

       • R. Temple

       Pages 125-134

   12. Objectives and achievements of regulations in Japan

       • C. N. Roberts

       Pages 135-148

   13. Objectives and achievements of regulations in developing countries

       • D. C. Jayasuriya

       Pages 149-162

5. Back Matter

   Pages 163-165

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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.

• cognition
• developing countries
• development
• medicine
• regulation
• research

• Welsh School of Pharmacy, Cardiff, UK

  Stuart R. Walker

• The Association of the British Pharmaceutical Industry, London, UK

  John P. Griffin

• DHSS, London, UK

  John P. Griffin

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