The Guideline on good pharmacovigilance practices (GVP) now comprisese several updates:
On 8 August 2016, draft revision 2 of Module VI on management and reporting of adverse reactions and draft revision 1 (major revision) of Module IX on signal management with its Addendum I (Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions) were released for public consultation until 14 October 2016.
The draft documents contain the following updates and amendments, which are highlighted in the respective documents:
GVP Module VI:
- Update on the electronic reporting modalities of ICSRs (Individual Case Safety Report) under the new ICH-E2B(R3) format;
- Update on ICSRs reporting, following-up, duplicate detection, data quality management, in line with the provisions in Art. 24 of Reg. (EC) No 726/2004, Art. 107 and 107a of Dir. 2001/83/EC;
- Update on the validation of ICSRs based on patients and reporters identifiability;
- Update on the management of ICSRs described in the scientific literature;
- Update on the collection of information on patient’s age;
- Guidance on the management of suspected adverse reactions reported through medical enquiry and product information services;
- Guidance on the management of reports from post-authorisation efficacy studies;
- Transfer of the guidance on Emerging Safety Issue to GVP Module IX;
- Editorial amendments to align the format with other GVP Modules.
GVP Module IX with its new Addendum I:
- Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.C.3.1.);
- Streamlined information on scientific aspects of signal management (IX.B.2. to 4.), statistical aspects now addressed in Addendum I;
- Clarifications on terminology (IX.A.1.), roles and responsibilities (IX.C.1.) and processes (IX. Appendix 1);
- Criteria for access by marketing authorisation holders to case narratives held in EudraVigilance, with reference to Revision 2 of the EudraVigilance Access Policy (IX.C.2.1.);
- Updated guidance on the periodicity of monitoring of EudraVigilance data (IX.C.2.2.);
- Procedural options for signals validated by marketing authorisation holders (IX.C.3.).
On the following questions the agency seeks specific feedback:
- Are the proposed criteria for access to case narratives held in EudraVigilance by marketing authorisation holders acceptable (see IX.C.2.1.)?
- Are the recommendations regarding the frequency of monitoring of EudraVigilance data acceptable (see IX.C.2.2.)?
- Are the proposed timelines and modalities for communication of emerging safety issues and validated signals by marketing authorisation holders clear and acceptable (see IX.C.3.)?
Additionally, the Product- or Population-Specific Considerations P.II on biological medicinal products were published as final on 15 August 2016, having been amended in the light of their public consultations.
Furtheremore, Module VIII – Post-authorisation safety studies (Rev 2) and Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 2) were published as final on 8 August 2016.
For more Information please visit the EudraLex - Volume 9 Pharmacovigilance Guidelines website.