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International Medicines Regulations

A Forward Look to 1992

  • Book
  • © 1989

Overview

Editors:
  1. Stuart R. Walker

    1. Welsh School of Pharmacy, Cardiff, UK

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  2. John P. Griffin

    1. The Association of the British Pharmaceutical Industry, London, UK
      DHSS, London, UK

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: CMR Workshop Series (CMRWS)

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Table of contents (25 chapters)

  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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Keywords

About this book

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.

Editors and Affiliations

  • 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

Bibliographic Information

  • Book Title: International Medicines Regulations

  • Book Subtitle: A Forward Look to 1992

  • Editors: Stuart R. Walker, John P. Griffin

  • Series Title: CMR Workshop Series

  • DOI: https://doi.org/10.1007/978-94-009-0857-4

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Kluwer Academic Publishers 1989

  • Softcover ISBN: 978-94-010-6873-4Published: 12 October 2011

  • eBook ISBN: 978-94-009-0857-4Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: 288

  • Topics: Pharmacology/Toxicology, Medical Law

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