Countries | Stability Condition | Stability Commitment while Filling | Number of Submission Batches | Bio equivalence Requirement | Dissolution Requirement |
EU | Long term Accelerated Intermediate | On Three commercial batches | Two batches: one lacks units | Fast, Fed if required | Minimum in 3 media |
US | One batch: one lacks units | Fast and Fed both | Only official media | ||
Russia | Optional | Three batches: one lacks units | Fast and Fed both | Minimum in 3 media | |
Asia | Accelerated Intermediate | N/A | Three representative batches | Only for epileptic drug | N/A |
Africa | Long term Accelerated | Optional | Two batches: one lacks units | Fast or Fed | Minimum in 3 media |