Hey,
In my experience, extension of the shelf-life can be submitted in annual reports, provided that a protocol defining the criteria for extension of the shelf-life has been previously submitted and approved by the agency. A reduction in shelf-life would need to be submitted as an amendment.
Refer to FDA's "Guidance For Industry: INDs for Phase 2 and Phase 3 Studies" May 2003.
Or the EMA guidance: "Guideline on the requriements for quality documents concerning biological investigational medicinal products in clinical trials"
cheers,
Catherine
------------------------------
Catherine Campbell PhD RAC
Biomarin Pharmaceuticals
Novato CA
United States
------------------------------
Original Message:
Sent: 09-Apr-2017 16:32
From: Narayan Rao
Subject: re-labeling IMP
All CMC changes require an information amendment to an IND prior to implementation, except maybe submitting stability data, which can be done in an IND AR.
------------------------------
GRSAOnline
------------------------------
Original Message:
Sent: 06-Apr-2017 16:43
From: Anonymous Member
Subject: re-labeling IMP
This message was posted by a user wishing to remain anonymous
A study vaccine needs to be re-labeled with a new re-test date (manufacturer decided to use re-test date on original label instead of expiry date). The manufacturer will conduct stability and potency tests to support the new re-test dates. Should this information be submitted a priori as an information amendment or can it be included in the next annual report. There is some debate among the regulatory folks.thanks