Regulatory Requirements

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.