ICH E2C, in conjunction with its addendum, has been adopted by the Japanese Ministry of Health, Labour and Welfare and included in Volume 9 of the Rules Governing Medicinal Products in the Euro-pean Union, on pharmacovigilance (EC, 2004a).
REGULATORY REQUIREMENTS
ICH
E2C, in conjunction with its addendum, has been adopted by the Japanese
Ministry of Health, Labour and Welfare and included in Volume 9 of the Rules Governing Medicinal Products in the
Euro-pean Union, on pharmacovigilance (EC, 2004a). The US Food and Drug Administration (FDA) has also introduced periodic
reporting requirements based on ICH E2C, and it published a guidance for
industry in February 2004 (FDA, 2004). ICH E2C has therefore made its mark in
all three ICH regions. However, the reporting requirements in those regions
differ:
·
in the EU, Council Directive 93/39/EEC and Coun-cil
Regulation 2309/93 require that reports be submitted every 6 months for the
first 2 years after authorisation, annually for the three following years and
then five yearly after the first renewal;
·
in the United States, the FDA requires quar-terly reports
during the first 3 years, then annual reports and
·
in Japan, the authorities require a survey on a cohort of a
few thousand patients established by a certain number of identified
institutions during the 6 years following authorisation. Systematic
infor-mation on this cohort, taking into account a precise denominator, must be
reported annually. Regard-ing other marketing experience, adverse reactions
which are non-serious, but both mild in severity and unlabelled, must be
reported every 6 months for 3 years and annually thereafter.
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