The Danish regulator identified a big error with the draft revision of the pharmacovigilance guideline leading to its revision by the EMA. The error was spotted in the draft version of the GVP module VI, in which a chart depicts ICSRs received by the Eudravigilance system being routed to the National Competent Authorities and MAHs. The chart instructs the NCAs and MAHs to merge any ICSRs which are duplicates, if identified by the NCAs and MAHs, and inform the EMA of their action. The Danish regulator pointed out a problem with this process, stating “The DKMA sees a big problem with the proposed procedure. If both the MAHs and NCA are responsible for merging the duplicates, there is the possibility that the different senders will identify the duplicates on the same day and merge them simultaneously”.

The DKMA has suggested only the NCAs should merge duplicates and MAHs should inform the NCAs if they identify any duplicates. It is then up to the NCAs to decide whether to merge the two ICSRs or not.

Having received and considered this feedback from the DKMA and various other stakeholders, the EMA has updated its guidance with a slightly different model. The EMA will be responsible for merging duplicate cases. If the NCAs or MAHs identify any duplicate ICSRs, they will forward the cases directly to the EMA who will then merge them into one master case. The Agency will inform the NCAs and MAHs of their action. This is an example of just one amendment the EMA has made following feedback received from the public consultation.

The European Federation of Pharmaceutical Industries and Associates (EFPIA) has criticized the draft for making the requirements for the MAHs and NCAs “unnecessarily specific”, viewing them as undesirable given the fast-moving pace of pharmacovigilance.

In response to the feedback from the EFPIA, the EMA has revised its guidance and has now included advice on the management of ICSRs arising from off-label use, which was absent in the draft.

However, in some areas the EMA has opted to go against the advice of the EFPIA and other stakeholders. The most significant being their decision to release a final version of the guidance, rather than issue a second draft for public consultation. The final version will be issued on 22 November 2017.