Minimum stability data required at the time of filing a generic product application

The previous exception to allow 3 months stability data (at time of submission) for RH and 2nd line TB products was made, as an interim measure, to encourage the submission of poorly-represented products on the prequalified list. After implementing this exception for 8 years it has been re-evaluated, and it has been concluded that there is no longer need, or advantage to such a measure.

The minimum stability requirements for all products at the time of submission to PQT-m are 6 months accelerated and 6 months long-term stability data. This is in line with most major regulators (ref).

Ref WHO Drug Information vol. 30, no.3, 2016