EMA: New Q&A on Product Lifecycle Management (PLCM)
The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.
What is a PLCM?
A PLCM document is a voluntary regulatory tool to proactively manage CMC changes throughout the product lifecycle. It follows the principles of ICH Q12 and supports global harmonisation of post-approval changes.
Keypoints:
- Use is optional
- Submission via Type II variation only
- Located in CTD Module 3.2.R
- All changes to binding dossier elements still require standard EU variations
- GMP compliant sites and an effective PQS are prerequisites
Source:
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