0      0

T101b - ICH Q12 EU Implementation and Short Update on the Revision of Q5A and the On-going Work in QDG

‐ May 12, 2020 12:45pm

The guideline, ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, is intended to work with ICH Q8 to Q11 Guidelines and will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The guideline has been under development since 2014 and in November 2019 it was finalized by the Expert Working Group. In EU, the guideline and its annexes were published at the EMA webpage on 4. March 2020. The Q12 guideline was thereby implemented in EU. An implementation note was published on the EMA webpage together with the guideline. Full implementation of all elements of Q12 is not possible at this stage as some parts are not considered compatible with the existing EU legal framework on variations. This presentation will give a short introduction to ICH Q12 and give and the implementation in EU will be illustrated. In addition, the presentation will give a short update on the revision of ICH Q5A and share information on the on-going work in ICH Quality Discussion Group (QDG)


You must be logged in and own this session in order to post comments.