EU: EMA GVP Module VIII Rev 2 Released for Consultation (Aug 2015)

Revision 2 of EMA GVP Module VIII has been released for public consultation

Revision 2 contains the following:

• Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and categories 1-4 of non-interventional PASS described in GVP Module V;
• Changes to VIII.B.3.1., adding text in line with GVP Module VI Rev 1 to provide a recommendation on adverse events that will not be collected or reported;
• Changes to VIII.B.3. and XIII.B.4. with the sentence referring to the notification of substantial amendments to PASS protocols, progress reports and final reports to the Agency for centrally- authorised products moved to GVP XIII Addendum I Rev 2;
• Changes to VIII.B.8. with additions from previous VIII.C.3., removing duplication of text;
• Changes to VIII.C.2.d., specifying that the definition of the core elements of a PASS protocol will normally be a first step in the process leading to joint studies, prior to the agreement (or not) of a joint study by different marketing authorisation holders;
• Updating of the structure to bring the Module in line with other GVP Modules as structuring has consolidated over time (previous B.1. and C.1 on scope moved to A and previous B.2. moved
• Editorial amendments throughout the Module;
• Revision of nearly all Sections of VIII.Appendix 1 in order to:
  • provide updated and more detailed information on some study designs;
  • revise the terminology where needed.