EMA GVP Annex IV

EMA Final GVP Annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance

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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step...(PDF/177.91 KB)

First published: 01/06/1995, Last updated: 01/06/1995

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements ...(PDF/1.49 MB)

First published: 01/09/2005, Last updated: 27/08/2013

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety repo...(PDF/480.36 KB)

First published: 01/03/2005, Last updated: 27/07/2017

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5 (PDF/476.27 KB)

First published: 31/12/2012, Last updated: 31/12/2012

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5 (PDF/181.92 KB)

First published: 30/11/2003, Last updated: 30/11/2003

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5 (PDF/225.43 KB)

First published: 31/12/2004, Last updated: 31/12/2004

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2F on development safety update report - Step 5 (PDF/352.87 KB)

First published: 30/09/2010, Last updated: 30/09/2010

EMA GVP Annex IV: