Regulatory Requirements

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

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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