Good Morning,

I have a question regarding the shift from CTD to CTR.

We’ve released batches under CTD, and approval has now been obtained to transition the ongoing clinical trial to CTR. Do these batches need to be reworked, or can they be distributed during the transition period under CTR?

My understanding is that rework isn’t necessarily required if the IMP complies with the current IMPD and GMP standards. However, if the transition involves significant changes to the product, protocol, or labeling, modification may be needed before distribution. I believe this should be evaluated on a case-by-case basis.

Could you please provide guidance on how to interpret this?

Many thanks for your help!