Missing information relevant to the risk management planning refers to gaps in knowledge about the safety of a medicinal product for certainly anticipated utilisation (e.g. long-term use) or for use in particular patient populations, for which there is insufficient knowledge to determine whether the safety profile differs from that characterised so far. The absence of data itself (e.g. exclusion of a population from clinical studies) does not automatically constitute a safety concern. Instead, risk management planning should focus on situations that might differ from the known safety profile. A scientific rationale is needed for the inclusion of that population as missing information in the RMP.
Presentation of missing information data:
- name of the missing information (using MedDRA terms when appropriate);
- evidence that the safety profile is expected to be different than in the general target population;
- description of a population in need of further characterisation, or description of the risk anticipated in the population not studied, as appropriate.
Missing information relevant to the risk management planning refers to gaps in knowledge about the safety of a medicinal product for certainly anticipated utilisation (e.g. long-term use) or for use in particular patient populations, for which there is insufficient knowledge to determine whether the safety profile differs from that characterised so far. The absence of data itself (e.g. exclusion of a population from clinical studies) does not automatically constitute a safety concern. Instead, risk management planning should focus on situations that might differ from the known safety profile. A scientific rationale is needed for the inclusion of that population as missing information in the RMP.
Presentation of missing information data:
- name of the missing information (using MedDRA terms when appropriate);
- evidence that the safety profile is expected to be different than in the general target population;
- description of a population in need of further characterisation, or description of the risk anticipated in the population not studied, as appropriate.
