Table Of ContentInternational
Medicines
Regulations
A Forward Look to 1992
CMR Workshop Series
Monitoring for Adverse Drug Reactions
Editors: S.R. WalkerandA. Goldberg
Long-Term Animal Studies
Their Predictive Value for Man
Editors: S.R. Walker and A.D. Dayan
Medicines and RisklBenefit Decisions
Editors: S.R. Walker and A. W. Asscher
Quality of Life: Assessment and Application
Editors: S.R. Walker and R.M. Rosser
International Medicines Regulations -
A Forward Look to 1992
Editors: S.R. Walker and J.P. Griffin
Animal Toxicity Studies -
Their Relevance for Man
Editors: C.E. Lumley and S.R. Walker
~
Workshop Series
International
Medicines
Regulations
A Forward Look to 1992
EDITED BY
Stuart R. Walker
Director of the Centre for Medicines Research
Carshalton, and Honorary Professor, Welsh School of Pharmacy, Cardiff
and
John P. Griffin
Director, The Association of the British Pharmaceutical Industry, London
Formerly Professional Head of the Medicines Division, DHSS, London
Proceeedings of the Centre for Medicines Research Workshop held at the
elBA Foundation, London, 20th/21st September 1988
~ KLUWER ACADEMIC PUBLISHERS
••~ - DORDRECHTI BOSTON I LONDON
Distributors
for the United States and Canada: K1uwer Academic Publishers,
PO Box 358, Accord Station, Hingham, MA 02018-0358, USA
for all other countries: K1uwer Academic Publishers Group,
Distribution Center, PO Box 322, 3300 AH Dordrecht, The Netherlands
British Library Cataloguing in Publication Data
Centre for Medicines Research. (Workshop: 1988 : elBA
Foundation).
International medicines regulations: a forward look to
1992 : proceedings of the Centre for Mediciines Research
Workshop held at the CIBA Foundation, London, 20th/21 st
September 1988. - (CMR workshop series, 5).
1 Drugs. Regulation
I. Title II. Walker, Stuart R. (Stuart Russel), 1944
III. Griffin, John P. IV. Series
363.1'946
ISBN-13: 978-94-010-6873-4 e-ISBN-13: 978-94-009-0857-4
DOl: 10.1007/978-94-009-0857-4
Copyright
© 1989 by K1uwer Academic Publishers
Softcover reprint of the hardcover 1st edition 1989
All rights reserved. No part of this publication may be reproduced,
stored in a retrieval system, or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording or otherwise,
without prior permission from the publishers, K1uwer Academic
Publishers BV, PO Box 17, 3300 AA Dordrecht, The Netherlands.
Published in the United Kingdom by K1uwer Academic Publishers,
PO Box 55, Lancaster, UK.
K1uwer Academic Publishers BV incorporates the publishing
programmes of D. Reidel, Martinus Nijhoff, Dr W. Junk and MTP Press.
Contents
Preface ix
Notes on Contributors xi
SECTION I HISTORICAL DEVELOPMENT AND ROLE
OF REGULATIONS
1 The historical development of medicines regulations
RDMann 3
2 Setting the scene - the role of regulation
LLasagna 19
3 An international comparison of medicines regulations
MNGDukes 27
Discussions points 35
SECTION II OBJECTIVES AND ACHIEVE:MENTS OF
REGULATIONS
4 Objectives and achievements of regulations in West
Germany
G Lewandowski 39
5 Objectives and achievements of regulations in West
Germany
RBass 47
6 Objectives and achievements of medicines regulations in
the BENELUX countries
P Claessens and J Muschart 59
7 Objectives and achievements of regulations in The
Netherlands
C A Teijgeler 67
8 Objectives and achievements of regulations in the UK
J PGriffin 73
v
INTERNATIONAL MEDICINES REGULATIONS
9 Objectives and achievements of medicines regulations in
the UK
MDRawlins 93
10 The Swedish medicines regulatory system - with some
notes on the Scandinavian situation
LEBottiger 101
11 Objectives and achievements of medicines regulations in
the Nordic countries
J Idanpiiiin-Heikkiia 111
12 Objectives and achievements of regulations in the USA
JR Crout 117
13 Objectives and achievements of regulations in the USA
R Temple 125
14 Objectives and achievements of regulations in Japan
CN Roberts 135
15 Objectives and achievements of regulations in developing
countries
D C Jayasunya 149
Discussion points 163
16 Overview of objectives and achievements of medicines
regulations
H HTilson 167
SECfION III FUTURE PERSPECTIVES OF
REGULATIONS IN JAPAN AND THE UNITED STATES
17 Future perspectives of regulations in Japan
KUchida 173
18 Future perspectives of regulations in the United States
RTemple 185
19 Future perspectives of regulations - industry viewpoint
CCLeighton 195
Discussion points 203
SECfION IV FUTURE PERSPECfIVES OF
REGULATIONS IN THE EUROPEAN ECONOMIC
COMMUNITY
20 The role of the CPMP in the EEC
C A Teijgeler 207
vi
CONTENTS
21 Future perspectives of regulations - internal market by
1992?
F Sauer 219
22 Future perspectives of regulations - harmonization of data
requirements
B A Gennery 235
23 Future perspectives of regulations - national authorities'
relationship with the EEC
D Poggiolini 243
24 Future perspectives of regulations - the concept of a
European medicines office
TMJones 249
25 Mutual recognition or a central European office?
Y Juillet 261
Discussion points 265
Final round table discussion 267
Appendix 1 The future systems in Europe
ABPI Steering Group for Europe 271
Appendix 2 Memorandum on the future system for the
authorization of medicinal products in the European
Community
Commission of the European Communities Memorandum 289
Index 307
vii
Preface
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. Walker
J.P. Griffin
ix
Notes on Contributors
Professor R Bass MD is Head of Toxicology, Director and Professor at the Institute
for Drugs of the Federal Health Office, Berlin and since 1984 has been Ausserplana
biger Professor of Pharmacology and Toxicology at the Free University Berlin. His
current research interests are in reproduction and short-term -tests in toxicology. He
has had over 90 papers, articles and books published in this area on formaldehyde,
animal experiments and protection and regulatory toxicology.
Professor L E Biittiger MD FRCP is Vice President and Head of Medical Affairs,
KabiVitrum Ltd., Stockholm, Sweden. He has been Professor and Head of the
pharmacotherapeutic Division of the Department of Drugs (1972-1974) and Pro
fessor and Chairman, Department of Internal Medicine, Karolinska Institute and
Hospital, Stockholm, Sweden (1974-1984). He has published more than 400 articles
in internal medicine, clinical pharmacology and related areas.
Mr P Claessens Dr Juris MBA is Managing Director of the Association Generale
de I'Industrie du Medicament, Belgium. He is a Member of the Executive Committee
of the European Federation of Pharmaceutical Industries' Associations, a Member
of the Pricing Committee of the Belgian Ministry of Economic Affairs and the
Belgian National Institute for Social Security. In the past he has held the post of
Director at the Belgian Federation of the Chemical Industry and Assistant to the
Managing Director of BASF, Belgium.
Dr J R Crout MD is Vice President, Medical and Scientific Affairs, Boehringer
Mannheim Pharmaceuticals Corporation, Rockville, Maryland, USA. Prior to as
suming this position he was Director, Bureau of Drugs, US Food and Drug Admin
istration, Rockville, Maryland and later Director, Office of Medical Applications of
Research, National Institute of Health, Bethesda, Maryland. His research interests
are in clinical pharmacology, hypertension, autonomic pharmacology, new drug
development, clinical trial design and management and drug regulatory policy.
Professor M N G Dukes MD MRCS LRCP MA LLM (International Law) is
Professor of Drug Policy Science at the University of Groningen, Regional Officer
for Pharmaceuticals at the WHO Regional Office for Europe in Copenhagen and
Editor in Chief of the Side Effects of Drugs volumes and database. His research
interests include the scientific basis of pharmaceutical drug policies, the sociology of
drug utijization, adverse reaction monitoring, the influence of clinical pharmacology
and the apportionment of responsibility for drug-induced injury.
Dr B A Gennery MB ChB Dip Pharm Med is Group Medical Director for Europe
for Lilly Research. He qualified in medicine at the University of Bristol. After nearly
ten years in clinical medicine he joined Boehringer Ingelheim where he was re
sponsible for clinical research and medical services for rheumatological, cardiovascu-
xi
INTERNATIONAL MEDICINES REGULATIONS
lar and respiratory products. He has published papers on cardiovascular and rheuma
tological products and research in biotechnology.
Dr J P Griffin BSc PhD MB BS MRCP FRCPath has been Director of The
Association of the British Pharmaceutical Industry since 1984 and is Honorary
Consultant at the Lister Hospital, Stevenage, Herts. Formerly he was Professional
Head of Medicines Division, Department of Health, UK representative to the EC
Committee of Proprietary Medicinal Products (CPMP) and Chairman of the
CPMP's Working Party on Safety Requirements (1977-1984). He was also a Mem
ber of the Editorial Board of British National Formulary between 1976 and 1984.
Dr Griffin is the author of four books and over 150 scientific papers.
Professor R Hurley LLB MD FRCPath DUniv(Surrey) DipLit of the Inner Temple
Barrister-at-Law is Professor of Microbiology at the Royal Postgraduate Medical
School's Institute of Obstetrics and Gynaecology, University of London, and Chair
man of the Medicines Commission. Her current research interests include studies
on the diagnosis, incidence, aetiology, management and prognosis of serious infec
tions of the central nervous system, infections, particularly viral infections, during
pregnancy, and the mycoses caused by Candida albicans, She has written two books
on the latter and has contributed many chapters in standard textbooks of Medicine
and of Obstetrics and Gynaecology on various topics, as well as publishing research
papers.
Dr J Idanpaan-HeikkiJa MD is Medical Officer for Pharmacology and New Drug
Evaluation at the Health Directorate of Finland in Helsinki, Finland. He is a member
of the WHO Advisory Panel for Drugs and Therapeutics and Associate Professor
of Pharmacology at the University of Helsinki Medical School. His main research
interest has been in psychopharmacology, drug utilization and drug regulations.
Dr D C Jayasuriya LLB PhD is an international consultant on health policy and
legislation and has recently established an Institute of Comparative Health Policy
and Law. He is the author of 12 books, six monographs and over 100 articles.
Professor T M Jones BPharm PhD FPS CChem FRSC MCPP is currently the
Director of Research, Development and Medical, Wellcome Foundation Ltd and
also Director of Wellcome's Beckenham site. He is responsible for all R&D and
medical activities in the UK and overseas (excluding the USA) and is a Main Board
Director. Professor Jones is Visiting Professor of Pharmacy, University of London
and Adjunct Professor in Pharmaceutics, University of North Carolina, USA. He is
a member of many academic and industrial committees, sits on the editorial boards
of a number of pharmacy and pharmaceutical journals and has authored numerous
publications throughout his career. He was appointed by the UK Minister of Health
to the Medicines Commission in 1982.
Dr Y Juillet MD is a specialist in internal medicine, cardiology and pharmacology
and has been Deputy Managing Director of SNIP since 1988. Prior to this appoint
ment he was Director of Scientific & Technical Affairs of SNIP and Associate
Professor and Departmental Head at Hopital Broussais, Paris. He is a Member of
the official registration Committee (AMM) , Transparency and Post Marketing
Committee of the French Health Ministry where he represents Industry and is
currently Vice President of the European Federation of Pharmaceutical Industries'
Association's Working Party 1.
Professor L Lasagna MD is Dean of the Sackler School of Graduate Biomedical
Sciences and Academic Dean of the School of Medicine, Tufts University, Boston,
Massachusetts, USA. Professor Lasagna's research interests have included analges
ics, the placebo response, clinical trial methodology and drug development and
xii
