Generic companies frequently face challenges on signal management, which may impact updates to product information related to safety concerns especially when these originate externally. 

Competent authorities expectations are similar for innovative and generic marketing authorization holders in respect to the signal management. Based on the regulations and information received from the authorities “sufficient evidence” is needed for safety variations for Generics, as well as for the innovative products.  

However, in practice signals submitted by the generic MAH many a times face rejection or placed on hold on the grounds of “insufficient evidence”, in particular when the reference product label doesn’t include the respective safety topic.

Learn from Mohamed Ali Kotal, Head Medical Safety at Sandoz, speaking at the 3rd Pharmacovigilance & Drug Safety Conference in Lisbon on 6 & 7 June.

Mohamed Ali Kotal

Head Medical Safety

Sandoz