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ICH Q12 WG
About this WG
ICH Q12 WG is a multi-sectional working group (WG) within PMDA.
The purpose of ICH Q12 WG is to discuss regulatory issues related to ICH Q12*.
*ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle) is one of the quality guidelines which is being discussed in the International Council for Harmonisation (ICH).
ICH Q12 is proposed to provide guidance on 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.
Established
May, 2015
Members
Office of New Drug I-V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Manufacturing/Quality and Compliance
Office of Research Promotion
Past Presentations
| Date |
Presentation Title |
Place |
| Dec. 2017 |
How Will ICH Q12 Fly in Japan? |
CMC Strategy Forum Japan 2017, Tokyo, Japan |
| Nov. 2017 |
ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective |
14th Annual Meeting, DIA Japan
2017, Tokyo, Japan |
| Dec. 2016 |
Connection from ICH Q12 (ECs) to
Application Form (Approved Matters)
PMDA Perspective on Established
Conditions for Specification -in connection with Japanese Application Form-
Established Conditions for manufacturing
process –PMDA perspective
|
CMC Strategy Forum Japan 2016, Tokyo, Japan |
| Nov. 2016 |
ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
|
13th Annual Meeting, DIA Japan
2016, Tokyo, Japan
|
|
Jul. 2016
|
Post-Approval CMC Changes in Japan: How We Envision the Future
|
CMC Strategy Forum Summer
2016, Gaithersburg, USA
|
|
Apr. 2016
|
ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
|
ISPE Japan Affiliate 2016 Annual Meeting, Tokyo, Japan
|
|
Nov. 2015
|
ICH Q12 (Pharmaceutical Product Lifecycle Management): Current Status and Future Perspectives
|
CMC Strategy Forum Japan 2015, Tokyo, Japan
|
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