FDA Draft Guidance - ICH Q12: Implementation Considerations

On 19 May 2021 the FDA issued draft guidance for industry titled “ICH Q12: Implementation Considerations for FDA-Regulated Products”. Comments on this draft document should be sent to FDA by 19 July 2021.

Given that we are still waiting for any published output from the Q12 Implementation Working Group this document provides some insight on FDA’s expectations, especially around Established Conditions (ECs), which was an FDA concept to start with.

The draft guidance makes extensive recommendations for Established Conditions (ECs):

1.      Submission of ECs

Applicants may propose ECs in their original applications or in a prior approval supplement (PAS).

2.      Identification of ECs

3.      Identification of ECs for a Drug Substance or Drug Product in a Drug Master File

4.      Identification of ECs for Device Constituent Parts of Combination Products

5.      Changes to Approved ECs

6.      Post-approval Submissions in Accordance With Approved ECs

7.      Maintenance of the Application

The draft also has sections on other key parts of Q12:

·        Post-approval Change Management Protocol

·        Product Lifecycle Management Document

·        Pharmaceutical Quality System and Change Management

·        Relationship Between Regulatory Assessment and Inspection

·        Structured Approaches for Frequent CMC Post-approval Changes and Stability Data Approaches To Support the Evaluation of CMC Changes