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Guideline
Dr Frank Montgomery, Global Head, Reg CMC, AstraZeneca/Medimmune
Q12 EFPIA Expert
CMC Strategy Forum Japan 2016 6th Dec 2016
Outline
2
Q12 Scope and Objectives
• Scope
• The proposed guideline will apply to pharmaceutical products,
including marketed products, chemical, biotechnological and
biological products
• 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
3
Regulatory Agencies Involved in Q12
• ICH regions
• US FDA, EU, MHLW/PMDA, Health Canada,
Swissmedic
• New Members
• ANVISA (Brazil), MFDS (Korea)
• Observers
• WHO, TFDA (Chinese Taipei), HSA (Singapore),
4
Progress in Osaka
5
Table of Contents
1. INTRODUCTION
2. CATEGORISATION OF CHANGES
3. ESTABLISHED CONDITIONS
4. POST APPROVAL CHANGE MANAGEMENT PROTOCOL (PACMP)
5. PRODUCT SPECIFIC LIFECYCLE MANAGEMENT (PSLCM) STRATEGY
6. PHARMACEUTICAL QUALITY SYSTEM (PQS) AND CHANGE
MANAGEMENT
7. RELATIONSHIP BETWEEN ASSESSMENT AND INSPECTION
8. POST APPROVAL CHANGES FOR MARKETED PRODUCTS
9. GLOSSARY
10. ILLUSTRATIVE EXAMPLES, CASE STUDIES, AND TEMPLATES
2/14/2017 6
Categorisation of Changes
• Drug regulatory authorities are encouraged to utilise a system that
incorporates risk-based mechanisms for
• Requesting approval from the regulatory authority,
• Notifying the regulatory authority,
• Recording changes,
• Time frames for evaluation are commensurate with that potential risk
• Important to the efficient use of industry and regulatory resources
7
Established Conditions (EC)
9
Post Approval Change Management Protocol
(PACMP)
10
Product Specific Lifecycle Management Strategy
12
Marketed Products
14
Q12 EWG Workplan
15
Thank You!