Missing information

Gaps in knowledge about a medicinal product, related to safety or use in particular patient populations, which could be clinically significant.

It is noted that there is an ICH definition for important missing information, which is: critical gaps in knowledge for specific safety issues or populations that use the marketed product (see GVP Annex IV, ICH-E2C(R2) Guideline). The change of the EU term, to name this concept “missing information” rather than “important missing information”, is to be clear that in the EU a marketing authorisation cannot be granted if there are unacceptable gaps in knowledge, in accordance with Article 12 of REG (EC) No 726/2004 a marketing authorisation shall be refused if the quality, safety or efficacy are not properly or sufficiently demonstrated.