Applicants shall voluntarily or commission an agency who implements bioavailability and bioequivalence studies save samples of drugs (including test and reference products). Sufficient samples should be retained for at least five years after report is approved. Applicants should cooperate with the competent health authorities for retest and inspection. Applicant should do likewise even the study report has not been approved.

Any approved study protocol and report cannot be modified, unless modification is approved by the competent health authorities.

The Regulation takes effect starting from the date of promulgation.
The amended articles announced on 6th Mar, 2015 take effect starting from 1st Jan, 2016.