title: Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).
abstract: Marketing authorisations for medicines need to be based on the universal criteria quality, safety and efficacy, whilst taking into account local public health needs. With view to using resources efficiently and avoiding delay in access to medicines, scientific standards for investigating quality, safety and efficacy should be universal too. A major step to achieve this was taken in 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established between authorities and industry in the European Union (EU), Japan and the United States. Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of pharmacovigilance. Their development has to be seen in the context of initiatives taken in the three ICH Regions to strengthen pharmacovigilance. Most recently this involves making use of risk management concepts, reflecting new thinking of proactivity in pharmacovigilance. Moreover, consideration is given to regional and international cooperation beyond the ICH Regions.
authors.affiliation: European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK. priya.bahri@emea.eu.int
authors.forename: Priya
authors.initials: P
authors.lastname: Bahri
authors.forename: Panos
authors.initials: P
authors.lastname: Tsintis
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D016903:Drug Monitoring / Q000379:methods* / Q000592:standards / Q000639:trends; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D017891:Pharmacoepidemiology / Q000379:methods / Q000592:standards / Q000639:trends; D012308:Risk Management / Q000379:methods / Q000592:standards / Q000639:trends