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Proposed updates to GVP Module VI and what this might mean for our clients


Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The TGA and Medsafe also occasionally refer to the GVPs in their regulations and guidance documents. It is important to keep abreast of any major changes to the GVPs, so that we are best able to help clients prepare for necessary changes.

The new draft of GVP Module VI (Management and reporting of adverse reactions to medicinal products) was released for public consultation in August 2016, with a deadline for comments mid October 2016.  Of interest are the following proposed changes: 

  1. Definition/terminology changes and additions – The definition of Occupational Exposure has been amended (clarification that it means only the medicinal product and not active ingredients/excipients during manufacture), the definitions of Medication Error and Falsified Medicinal Product have been added.  These updates or new definitions may be important for clients in terms of capturing good quality information. 
  2. Electrowinnic reporting modalities of ICSRs under the new ICH-E2B (R3) format (becomes compulsory in June 2017) – there have been many changes made to Module VI with regards to ICH-E2B (R3).  MAHs will need to understand these changes and be able to adopt them before the deadline.  Two important changes include:
    1. The addition of ‘Primary Source for Regulatory Purposes’ which covers multiple sources by identifying the source of the worldwide case number (enabling global pharma companies/clients with SDEAs to identify duplicate cases)
    2. The ability to capture information on the seriousness of multiple adverse reactions in a single ICSR for each individual reported adverse reaction
  3. ICSR reporting, and data quality management – The addition of a sub-section called Nullflavours (a collection of codes specifying why a valid value is not present in an ICSR, e.g. a value is applicable but is unknown such as age of patient).  The client will have to be familiar with these codes to produce valid reports.  A new section on amendment and nullification of reports (might be applicable following an internal audit, where a report is found to be erroneous or in need of correction, but no follow-up information is available. With regards to data quality management, the section which discusses correct data entry has been moved to the Quality Management section.  
  4. Validation of ICSRs based on patients and reporters’ identifiability – At least one patient identifier must be available to consider the case validated for reporting (e.g. initials, gender, age, identification number).  Also the HCP must now be characterised by their qualification AND at least one of the following parameters; name, address or phone number.  If these identifiers are not present, it will not be considered a valid report. This will be important for clients to ensure that all of their reports are valid. 
  5. Management of ICSRs described in the scientific literature – There are changes to literature monitoring requirements for MAHs.  Exclusion criteria for the reporting of ICSRs published in the scientific literature has been listed.  The EMA will be performing monitoring of medical literature and will make available a list of active substances and medical literature subject to this monitoring.  This will affect clients’ processes with regards to literature monitoring. 
  6. Collection of information on patients’ age – More emphasis has now been placed on the importance of obtaining the patient’s age/age group.  This is especially important for identifying issues in elderly or paediatric populations. Clients should be aware of this, so that collection of age can be attempted in initial case or follow-up.  
  7. Guidance on spontaneous reports (management of suspected adverse reactions (not related to any organized data collection systems and which are notified through medical enquiry/product information services or which are consequent of the distribution of information materials), management of reports from post-authorisation efficacy studies, cases notified by different reporters, referring to the same patient and same suspected adverse reaction, and at least one notification is done in an unsolicited manner) – this will be important for MAHs to enable them to correctly identify spontaneous reports.
  8. Transfer of the guidance on Emerging Safety Issues to another GVP Module (Module IX) 

The proposed draft can be found on the European Medicines Agency website.


Call our experienced Pharmacovigilance Team on +61 3 9251 0777 to discuss how these changes might affect you

This article was written by Beverley Worrall, from our Pharmacovigilance Team

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