GVP Module VI (28 Jul 2017) updated

Collection, management and submission of reports of suspected adverse reactions to medicinal products

In preparation to the changes in EU PV towards the end of 2017, GVP Module VI has undergone extensive changes in Revision 2 [EMA/873138/2011]:

  • New guidance:
    • electronic submission modalities of ICSRs under the new ICH-E2B(R3) format
    • management of individual reports of off-label use, based on the Reflection Paper on Collecting and Reporting Information on Off-label Use in Pharmacovigilance [EMA/293194/2016], published for public consultation in 2016
    • management of reports from PAES
  • Updated guidance:
    • ICSR submission, follow-up, duplicate detection and data quality management, taking into account the implementation of the new EudraVigilance system, and of the simplified submission of ICSRs in the EU.
    • validation of ICSRs based on the identifiability of patients and reporters
    • management of ICSRs described in the medical literature
    • collection of information on patient’s age
    • management of suspected ADRs reported through medical enquiry and product information services
  • Transfer of the guidance on emerging safety issues to GVP Module IX

Date for coming into effect of Revision 2: 22 November 2017

Final: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/08/WC500232767.pdf

Tracked changes: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/08/WC500232768.pdf

GVP Module VI Addendum I (28 Jul 2017) new

Duplicate management of suspected adverse reaction reports /

This is a new GVP guideline [EMA/405655/2016] to replace the CHMP guideline on Detection and Management of Duplicate Individual Cases and Individual Case Safety Reports (ICSRs) pub. 7-Nov-11.

The document contains the following changes from the CHMP guideline:

  • Update of electronic reporting modalities of ICSRs in the new ICH-E2B(R3) format
  • Overall update on roles and responsibilities of different stakeholders in relation to the detection and management of duplicate reports of suspected ADRs
  • Guidance on how to inform the Agency of suspected duplicates in EudraVigilance

Date for coming into effect: 22 November 2017 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/08/WC500232765.pdf

GVP Product- or Population-Specific Considerations IV: Paediatric population (28 Jul 2017) draft for public consultation

On 02 Aug 2017, the EMA released this draft guideline [EMA/572054/2016] for public consultation.

This document outlines how different types of ADRs present within the paediatric population (including their limited number) and how they should be considered; paediatric subjects differ substantially from adults due to on‑going neurobehavioural development and physical growth, including internal organ maturation.

Implications to paediatric populations with relation to the growing number of PV documents are also discussed.

End of consultation (deadline for comments): 13 October 2017

Anticipated date for coming into effect after finalisation: Q1 2018


ICH guideline E2B (R3) - questions and answers (13 Jun 2017) updated

In June 2017, the following sections of this guideline [EMA/CHMP/ICH/3943/2003] were updated:

  • Section 4. Data elements
  • Section 7. Appendices