References
US Food and Drug Administration. 21 GFR 314.80 Federal Register 50 (30): 7500, 1985
Council for International Organizations of Medical Sciences. International reporting of adverse drug reactions, CIOMS, Geneva, 1990
Delamothe T. Reporting adverse drug reactions. British Medical Journal 304: 465, 1992
European Commission. CPMP Working Party. Notes for guidance 111/3976/88-EN. European Commission, Brussels, 1988
European Commission. Notice to applicants III73567/92, pp. 125–126, Brussels, 1993
International Committee on Harmonization. Clinical safety data management: definitions and standards for expedited reporting ICH-2 EWG E2, in press, 1994
Karch FE, Lasagna L. Adverse drug reactions. Journal of the American Medical Association 234: 1236–1239, 1975
Leon DA. Failed or misleading adjustment for confounding. Lancet 342: 479–481, 1993
Stephens MDB. Detection of new adverse drug reactions, 3rd ed., Macmillan Publishers Ltd, Basingstoke, 1992
Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD. Review of company post-marketing studies. British Medical Journal 304: 1470–1472, 1992
World Health Organization. Technical Report Series No 498, World Health Organization, Geneva, 1972
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Edwards, I.R., Biriell, C. Harmonisation in Pharmacovigilance. Drug-Safety 10, 93–102 (1994). https://doi.org/10.2165/00002018-199410020-00001
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DOI: https://doi.org/10.2165/00002018-199410020-00001