Individual case study reports (ICSRs) are being wrongly expedited to the MHRA as spontaneous cases.

The guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products; section VI.B.1.1.1. it states that: “A spontaneous report is an unsolicited communication by a healthcare professional, or consumer to a competent authority, marketing authorisation holder or other organisation (eg Regional Pharmacovigilance Centre, Poison Control Centre) that describes one or more suspected adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection systems where adverse events reporting is actively sought”.

 

 

1. If you receive an ADR report from another company’s clinical trial and your company’s drug is being used during the trial as an Investigational Medicinal Product (IMP) then all SUSARs during the trial will be reported by the sponsor marketing authorisation holder. There are no expedited reporting requirements for the non-sponsor marketing authorisation holder.
2. If you receive an ADR report from an EU company’s clinical trial and your drug is a Non Investigational Medicinal Product (NIMP) but is considered co-suspect along with an IMP then SUSARs from the trial will be reported by the sponsor marketing authorisation holder. There are no expedited reporting requirements for the non-sponsor marketing authorisation holder. Clinical trials from outside the EU should be reported to the EudraVigilance Post-Authorisation Module (EVPM) as a report from study. The MHRA should not be sent these cases.

In both of the cases above the non-sponsor marketing authorisation holder should record the case in their safety database as a solicited case and not spontaneous.

 

If you receive an ADR report from another company’s clinical trial and your drug is a Non Investigational Medicinal Product (NIMP) and the ADR only relates to NIMPs then the marketing authorisation holder should report this case as a spontaneous case with the NIMP as the suspect drug and the IMP as a concomitant medication (as the causality had been reported as unrelated).