ICH Q12 (Pharmaceutical Product Lifecycle Management) : PMDA Perspective
ICH Q12 (Pharmaceutical Product Lifecycle Management) : PMDA Perspective
ICH Q12 (Pharmaceutical Product Lifecycle Management) : PMDA Perspective
Objectives include:
• 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
• Optimization of industry and regulatory resources
• Support innovation and continual improvement and help to assure drug product
supply
Scope
Pharmaceutical products, including currently marketed chemical, biotechnological
and biological products. (However, each regulatory authority will decide whether
generic medicines can be included in the scope of this guideline.)
Regulatory Dossier
• Explore the development of a harmonised approach to “regulatory commitments” for inclusion in the guideline. Such
approaches could enable post approval changes that facilitate continual improvement and encourage the adoption of
innovative technologies.
• Delineate the appropriate level of detail and information necessary for regulatory assessment and inspection in the
dossier, in order to create a more enabling post approval change management system.
Module 1
Legally binding
(Application Form)
Module 2 (QOS)
Module 3
Module 1
Legally binding
(Application Form)
Module 2 (QOS)
Module 3
inspection
AF
review
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© 2016 DIA, Inc. All rights reserved. Modified from draft Q12 document
Japanese Application Form
MHLW MAHs
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