Clinical trial APIs do not require expiry or retest dates. You should refer to Section 19.8. Expiry and retest dating, as defined in Section 11.6, applies to existing APIs used in clinical trials. So if you have a currently marketed one that someone’s using in a new dosage form, than, yes, obviously your API at that point is an established one, it will have it. For new APIs, Section 11.6 does not normally apply to early stages of clinical trials.
