- ABRAHAM , J. 1994 . Negotiation and accommodation in expert medical risk assessment and regulation: an institutional analysis of the benoxaprofen case . Policy Sciences , 27 : 53 – 76 .
- ABRAHAM , J. 1995 . Science, Politics and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation , London : UCL Press/Taylor & Francis .
- ABRAHAM , J. and LEWIS , G. 2000 . Regulating Medicines in Europe: Competition, Expertise and Public Health , London : Routledge .
- ABRAHAM , J. and SHEPPARD , J. 1999 . The Therapeutic Nightmare: The Baffle Over the World's Most Controversial Sleeping Pill , London : Earthscan .
- ANON . 1991 . ICH--backroom politics, front-line science . Scrip , 1669 15 November : 18 – 20 .
- ANON . 1992a . ICH progress so far . Scrip , 1707 8 April : 14 – 15 .
- ANON . 1992b . WHO stresses interest in ICH . Scrip , 1708 10 April : 16
- ANON . 1993 . ICH2--status of tripartite harmonisation initiatives . Scrip , 1872 12 November : 19
- ANON . 1994 . ICH--preparing for Brussels . Scrip , 1963 4 October : 18 – 19 .
- ANON . 1995 . Product liability outlook in Japan . Scrip , 1992 20 January : 22
- ANON . 1996 . Trust--PhRMA's biggest challenge . Scrip , 2123 26 April : 13
- ANON . 1997a . ICH 'common technical document" . Scrip , 2246 4 July : 16
- ANON . 1997b . 'Too many me-toos" in EC . Scrip , 2287 25 November : 2
- ANON . 2000 . ICH progress on single dossier . Scrip , 2522 15 March : 17
- ARAGA , Y. 'Keynote address" . Proceedings of the Third International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- BANGEMANN , M. Welcome and Introduction: Welcome address by Mr Martin Bangemann, VicePresident of the Commission of the European Communities . Proceedings of the First International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- BROWN , J.S. , KAITIN , K.I. , McAUSLANE , N. , THOMAS , K.E. and WALKER , S.R. 1996 . Population exposure required to assess clinical safety: report to the ICH working group . Drug Information Journal , 30 : 17 – 27 .
- CECCHINI , P. 1988 . The European Challenge, 1992 , Aldershot : Wildwood House .
- CLAUDE , J.R. 1993 . Six months before ICH2: an overview on the harmonisation of the guidelines on toxicology . Comparative Haematology International , 3 : 174 – 177 .
- DAVIS , P. 1997 . Managing Medicines: Public Policy and Therapeutic Drugs , Buckingham : Open University Press .
- DEBOYSER , P. A common technical document for applications . Proceedings of the Fourth International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- FERRIS , M.J. 1992 . “ A review of the Japanese regulatory system ” . In Medicines: Regulation, Research and Risk , Edited by: GRIFFIN , J.P. Belfast : Queen's University Press .
- FLETCHER , P. 1990 . “ What can be learnt by examining the data in the files of regulatory authorities? ” . In Animal Toxicity Studies: Their Relevance f or Man , Edited by: LUMLEY , C.E. and WALKER , S.R. Lancaster : Quay Publishing .
- GARUTTI , R.J. Clinical safety data management: definitions and standards for expedited reporting . Proceedings of the Second International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- GIAQUINTO , A. A common technical document for applications . Proceedings of the Fourth International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- GORDON , A.J. Clinical safety data management ICH guideline recommendations and reasoning . Proceedings of the Second International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- HALLIDAY , R.G. , DRASDO , A.L. , LUMLEY , C.E. and WALKER , S.R. 1997 . The allocation of resources for R&D in the world's leading pharmaceutical companies . R&D Management , 27 : 63 – 77 .
- HODGKIN , C. 1996 . International harmonisation-the need for transparency . International Journal of Risk & Safety in Medicine , 9 : 195 – 199 .
- ICH . 27 October 1994a . “ Guideline on the Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions ” . 27 October ,
- ICH . 27 October 1994b . “ Clinical Safety Data Management: Definitions & Standards for Expedited Reporting ” . 27 October ,
- ICH . 29 November 1995 . “ Guideline on the Need for Carcinogenicity Studies of Phannaceuncals ” . 29 November ,
- ICH . 6 November 1996 . “ Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs ” . 6 November ,
- ICH . 16 July 1997 . “ Duration of Chronic Toxicity Testing in Animals ” . 16 July ,
- IFPMA . 1998 . “ A brief history of ICH ” . In ICH: Past and Future at
- IFPMA . 2000 . The Value and Benefits of ICH to Industry , IFPMA .
- MclNTYRE , A. 1999 . Key Issues in the Pharmaceutical Industry , Chichester : John Wiley .
- MICOSSI , S. Impact and implementation: regulatory perspectives . Proceedings of the Fourth International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- NAITO , H. The influence of harmonisation on industry strategies and relations between industry and regulators . Proceedings of the Fourth International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- NAKAJIMA , H. The ICH programme: accomplishments and impact on world health . Proceedings of the Third International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- NIGHTINGALE , S.L. Impact and implementation: regulatory perspectives (USA) . Proceedings of the Fourth International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- OKUNO , I. Clinical safety data management: definitions and standards for expedited reporting-Japanese industry's perspectives . Proceedings of the Second International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- POGGIOLINI , D. Research development and regulation: a background to harmonization . Proceedings of the First International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- REED-MAURER , P. 1994 . Restructuring the Japanese pharmaceutical industry . Scrip Magazine , May : 38 – 40 .
- Ross , C. 1994a . Japan's medical information transparency . Lancet , 343 4 June : 1418 – 1419 .
- Ross , C. 1994b . New drug approval process under scrutiny . Lancet , 344 15 October : 1075 – 1076 .
- SCALES , M.D.C. Safety: review of present guidelines' . Proceedings of the Third International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- SJOBERG , P. Data to support the extension of clinical trials . Proceedings of the Third International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- SMITH-HOLSTON , S. The implications of harmonisation: viewpoint from the USA . Proceedings of the Third International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- TANSEY , I.P. , ARMSTRONG , N.A. and WALKER , S.R. 1994 . 'Trends in Pharmaceutical Innovation: The Introduction of Products on to the UK Market, 1960-1989 . Journal of Pharmaceutical Medicine , 4 : 85 – 100 .
- WEISSINGER , J. 'Safety: discussion' . Proceedings of the First International Conference on Harmonisation . Belfast. Edited by: D'ARCY , P.P. and HARRON , D.W.G. IFPMA .
- WYATT-WALTER , A. 1995 . Globalisation, corporate identity and European technology policy . Journal of European Public Policy , 2 : 427 – 446 .
Trading risks for markets: The international harmonisation of pharmaceuticals regulation
Reprints and Corporate Permissions
Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?
To request a reprint or corporate permissions for this article, please click on the relevant link below:
Academic Permissions
Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?
Obtain permissions instantly via Rightslink by clicking on the button below:
If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.
Related research
People also read lists articles that other readers of this article have read.
Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.
Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.