The future European rules on medicines are not yet definitive. Charges of the responsible persons at the pharmacovigilance in industry have been detailed. Reporting of serious adverse drug reactions (ADRs) implies symmetrical obligations for industry and for the future Agency. Harmonization and standardization of requirements are lacking. It is rather disappointing that European projects to harmonize regulations have not gone as far as the conclusions of the Council for International Organizations of Medical Sciences (CIOMS) Working Groups.
Official Journal of the European Communities (O.J.E.C.). No. C 330/23, 31.12.1990: COM (90) 283 Final.
2.
Council for International Organizations of Medical Sciences (CIOMS).International reporting of adverse drug reactions. Final report of CIOMS Working Group, Geneva, 1990.
3.
MeyboomRHBRoyerRJ. Causality classification of pharmacovigilance centres in the European Community. Pharmacoepidemiology and Drug Safety.1985;1: 87–97.
