During the current pandemic, the reporting of adverse events related to the widespread use of medicinal products (including off-label use) for the treatment or prevention of the pathogen causing the pandemic may increase.
According to the Q&A document developed by the European Commission, EMA and the European medicines regulatory network, in case MAHs are unable to continue standard reporting operations, they should temporarily prioritize the reporting obligations as follows:
- serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- other serious ICSRs;
- non-serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- other non-serious ICSRs.
While in the present exceptional circumstances, some MAHs may have understandable difficulties complying with the relevant deadlines, it is essential that MAHs report all serious ICSRs within 15 days. Where MAHs make use of prioritization, they shall put a note in the PSMF recording such practice.
Regulatory Pharma Net is available to provide full support for any query and for the management of ICSRs.