Cross-reporting requirements for serious cases

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    Relatively new to Pharmacovigilance and would be very grateful for some guidance please:

    My scenario is a product approved in US and EU (but no clinical studies ongoing in either US or EU) and NDA holder/ MAH is Company#1, and the product is being studied in a clinical trial in Japan under a different Sponsor (Company#2, which has out licensed development rights from Company#1), I am trying to work out the cross-reporting requirements in US and EU from any SUSARs that might occur in the Japan clinical trial.

    I think, for a Japanese SUSAR, we would need to cross report to both FDA and EMA.  I get a bit confused whether the reports would be clinical trial 15-day reports (i.e. to IND rather than NDA and to EVCTM rather than EV postmarketing) even though there are no active clinical studies ongoing in US or EU, or if they are handled through post-marketing expedited safety reporting?  I also think we would need to ask the Japanese Sponsor to unblind the SUSAR in order to be sure that it was related, before submitting to FDA and EMA (but the Japanese Sponsor is not happy with doing this).  Is unblinding still essential in a scenario where the report is coming from a trial where we are not the direct Sponsor?

    As a related question, if a clinical study with the same product were to be started in EU while the trial was ongoing in Japan, would this change reporting requirements in Europe?

    Many, many thanks in advance.

    Charlotte Mason


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