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