ICH Q12 (Pharmaceutical Product Lifecycle Management) : PMDA Perspective

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13th DIA JAPAN Annual Meeting 2016

Breakthrough in Regulatory Science for Patient-Engaged Medical Treatment


November 13-15, 2016 | Tokyo Big Sight | Ariake

ICH Q12 (Pharmaceutical


Product Lifecycle Management):
PMDA Perspective
Yasuhiro Kishioka, Ph.D.
Principal Reviewer
Office of Cellular and Tissue-based Products
PMDA
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© 2016 DIA, Inc. All rights reserved. 2
Background
From ICH Q12 Concept Paper

ICH Quality Vision 2003


Develop a harmonised pharmaceutical quality system applicable across the
life cycle of the product emphasizing an integrated approach to quality risk
management and science
ICH Q8~Q11, Points to Consider, Q&As
[Current Situation]
The envisioned post-approval ‘operational flexibility’ has not been achieved as
the main emphasis at ICH to date has focused on early stages of the product
lifecycle.
The lack of harmonised approaches for technical and regulatory aspects for
lifecycle management can hinder innovation and continual improvement.

ICH Q12: Pharmaceutical Product Lifecycle Management


© 2016 DIA, Inc. All rights reserved. 3
Objectives and Scope
From ICH Q12 Concept Paper

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.)

© 2016 DIA, Inc. All rights reserved. 4


Issues to be addressed in ICH Q12
From ICH Q12 Concept Paper

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.

Pharmaceutical Quality System (PQS) aspect


• Establish criteria for a harmonised risk-based change management system based on product, process and/or clinical
knowledge that effectively evaluates the impact of change on quality, and, as applicable to safety and efficacy.
• Clarify expectations and reinforce the need to maintain a knowledge management system that ensures continuity of
product and process information over the product lifecycle.

Post-Approval Change Management Plans and Protocols


• Introduce the concept of a post-approval management plan that can be used to proactively identify post-approval
changes and the mechanism to submit and assess these changes by regulatory authorities (Assessors and Inspectors)
• Establish criteria for post-approval change management protocols that can be adopted by the ICH regions (enabling a
harmonised proactive approach for lifecycle management)
• Encourage enhanced product development and control strategy approaches (Quality by Design (QbD)) providing
opportunities for scientific and risk based foundations for post-approval change management plans.
© 2016 DIA, Inc. All rights reserved. 5
Regulatory Commitments/Established Conditions
Although the Common Technical Document (CTD) format has been
defined for a marketing application, there are no previously
harmonised approaches to defining what changes would require a
regulatory submission.
Established Conditions
• are legally binding information (or approved matters) considered
necessary to assure product quality.
• are contained in a regulatory submission, proposed by the applicant,
and approved by the regulatory authority.
• As a consequence, any change to Established Conditions necessitates a
submission to the regulatory authority that is consistent with regional
regulations or guidance; or as agreed upon during review and approval
of the marketing application.
© 2016 DIA, Inc. All rights reserved. 6
Approved Matters and Established Conditions

© 2016 DIA, Inc. All rights reserved. 7


Japan’s Effective/Efficient/Flexible Quality Regulation

Module 1
Legally binding
(Application Form)

Module 2 (QOS)

Module 3

Not-Changeable without Changeable without regulatory


regulatory procedures (PCA/MCN) procedures (PCA/MCN)
© 2016 DIA, Inc. All rights reserved. 8
Japan’s Effective/Efficient/Flexible Quality Regulation

Module 1
Legally binding
(Application Form)

Module 2 (QOS)

Module 3

Not-Changeable without Changeable without regulatory


regulatory procedures (PCA/MCN) procedures (PCA/MCN)
© 2016 DIA, Inc. All rights reserved. 9
Review Process of MAA with document flow
-Focus on CMC-

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AF and Review/Inspection -Focus on post-approval change-

inspection

AF
review

11
© 2016 DIA, Inc. All rights reserved. Modified from draft Q12 document
Japanese Application Form

MHLW MAHs

© 2016 DIA, Inc. All rights reserved. 12


Japanese Application Form/Approved Matters

Application Form (AF), found in Module 1.2, is a legally


binding document in Japan.
Essential elements to ensure pharmaceutical quality
should be described in AF.
A post-approval regulatory action is required if a MAH
changes the content in the AF (Approved Matters; AMs).
AMs (incl. PCA/MCN) are determined on a product-by-
product basis.
AF provides the transparency and flexibility in terms of
post-approval changes.
© 2016 DIA, Inc. All rights reserved. 13
Product Specific Lifecycle Management Strategy
The document summarizes the information relating to the
lifecycle management strategy for the product in one
location.
• Established Conditions (ECs)
• Report category for making changes of approved ECs
• Post-Approval Change management Protocols
• Post-approval CMC commitments (if applicable)
At the MAH’s discretion, the PSLCMS may also proactively identify
some of the company’s anticipated post approval changes.
It allows both MAHs and Regulatory Authorities to plan
well in advance of implementing post-approval changes
relevant to a product’s ECs.
© 2016 DIA, Inc. All rights reserved. 14
Product Specific Lifecycle Management Strategy

MAA: Marketing Authorization Application


PCA: Partial Change Application
Current Future??? MAA PCA
Established Conditions M1.2 M1.2  *
Post-approval change
M1.2 M1.2  *
(PAC) reporting categories
Post-Approval Change
Management Protocols N/A PSLCMS  *
(PACMPs)
Post-approval CMC Response to
commitments, if inquiry, PSLCMS  *
applicable Memorandum

Anticipated PAC N/A PSLCMS


*: only where changed

© 2016 DIA, Inc. All rights reserved. 15


Product Specific Lifecycle Management Strategy

Product Specific Lifecycle Management Strategy???


 PACMPs
 Post-approval CMC commitments
 Anticipated PAC

© 2016 DIA, Inc. All rights reserved. 16


Post Approval Change Management Protocol
a regulatory tool that provides predictability and
transparency in terms of the requirements and studies
needed to implement a change.
Questions and answers on post approval
change management protocols
(EMA/CHMP/CVMP/QWP/586330/2010)

PMDA has been considering the adoption of PACMP.


© 2016 DIA, Inc. All rights reserved. 17
Acknowledgements

ICH Q12 Expert Working Group


PMDA Q12 Team
(Masatoshi Morisue, Kentaro Hara, Satomi Yagi)
PMDA Q12 Working Group special thanks to Yoko Ogushi
AMED* research group (*: Japan Agency for Medical Research and Development)
special thanks to Haruhiro Okuda, Akiko Ishii-Watabe and Noriko
Katori
JPMA Biopharmaceutical Committee Technical Working Committee
JPMA General Regulation Subcommitte Regulatory Affairs
Committee
Colleagues in the Office of Cellular and Tissue-based Products
© 2016 DIA, Inc. All rights reserved. 18
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