Community legislation and guidance documents

• Regulations
• Directives
• Guidance Documents
• General Guidance Related to Electronic Reporting of ICSRs
• Clinical Trials
• Post-Authorisation

Guidance Documents

• Note for Guidance - EudraVigilance Human version 7.0 Processing of Safety Messages and Individual Case Safety Reports (ICSRs) (integrated in Volume 9A).
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• Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety (ICSRs) Revision 1.
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• Implementation Plan for the Note for Guidance EudraVigilance Human - Processing of Safety Messages and Individual Case Safety Reports (ICSRs) (Doc. Ref. EMEA/H/20665/04/Final, Revision 1).
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• Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety (ICSRs) Revision 2.
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• Implementation plan for the 'Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)' (EMA/H/20665/04/Final Rev. 2) Implementation plan revision 1.
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• Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRs) and Medicinal Products (MPRS) in Pharmacovigilance during the pre- and post-authorisation phase in the European economic area (EEA) (integrated in Volume 9A).
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• Note for Guidance on Regulatory Electronic Transmission of Individual Case Safety Reports (ICSRs) in Pharmacovigilance.
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• ICH M2 EWG - Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1).
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• Implementation plan for the 'Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)' (EMA/H/20665/04/Final Rev. 2)
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List of Pharmaceutical Dosage Forms

• ICH Harmonised Tripartite Guideline - Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements of Transmission of Individual Case Safety Reports E2B(R2)
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• E2B Implementation Working Group - Questions & Answers (R5)
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Clinical Trials

• Volume 10 - Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ('CT-3') , (2011/C 172/01)
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• Volume 10 - Guidance Documents applying to Clinical Trials - Questions & Answers, version 10 (April 2012) Download -NEW
• Volume 10 - Guidance Documents applying to Clinical Trials - Guidance on Investigational Medicinal Products (IMPs) and 'Non Investigational Medicinal Products' (NIMPs) (Rev. 1, March 2011)
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Post-Authorisation

Good pharmacovigilance practices (GVP).

• Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system.
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Last update: Wednesday, 6 July 2016.