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2018-10-26
1
Q4B: Implementation and OpportunitiesJANEEN SKUTNIK-WILKINSONHEAD QUALITY INTELLIGENCE BIOGENTOPIC LEADER ICH Q4B / EWG MEMBER ICH Q3D
Agenda
Current Challenges
How can China adopt/adapt
Q4B
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So what’s the problem??? 3
Pharmaceutical Companies are global
Patients are global Pharmacopoeias & Regulatory
systems are still local A new pathway to address
pharmacopoeial standards is necessary
The facts…… 4
Pharmacopoeias publish quality standards for ingredients, components and dosage forms for
approved products
Help promote public health through provision of these standards
Verification Differences that exist between the standards of the USP/JP/Ph.Eur/ChP. Have not led to public health issues
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5The existence of multi-country/nation
compendial standards creates barriers to trade without providing additional layers of
quality assurance for the patient and consumers
Future of Interchangeability: Evolution 6
Multiple Pathways• Mutual Acceptance of Major Pharmacopoeias• Enhancements to the current PDG process
• All new standards (chapters, monographs) should be prospectively harmonised and identical
• Implementation of sign-off text as-is• Open discussion and debate and consideration
of new pathways• Harmonisation of structure/content of global
pharmacopeoias• Agreement by regulators that a company may select
a single compendia as part of their control strategy
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Considerations
Organisations and Government bodies beyond those engaged in ICH need to participate
How do the changes in philosophy enable new ways of thinking
FDA’s membership in PIC/s FDA/EMA Review PilotCollaborations and agreements amongst regulators for
inspectionsWhich is far more significant to patients and has greater
patient impact than a compendial test Implementation of ICH Q8/9/10/11
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Points to Consider
Still some conflict over the role of testing within the Quality System Despite knowing we “cannot test quality in” the
focus on testing remains high (vs. other aspects of the Quality System)
The current paradigm is NOT aligned with a science and risk based approach
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Risks in maintaining current system 9
Unnecessarily complicates access to medicines
Creates a barrier to the implementation of ICH Q8/9/10/11/12 Drug development and filings
become complicated based on a lack of a single compendial standard
Adoption of risk principles from Q9 is stifled in the laboratory when there is insistence to comply with all pharmacopoeial standards
Risks???
Is there a true risk to patients (quality & safety) from China visiting the USA, if they had to take a medicine that was tested only to the USP requirement (or vice-versa)?
Is there a risk on that basis alone?
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Benefits of a new system 11
Provides industry, regulators and patients with a single standard
Coordination of resources (regulators/pharmacopoeias/industry)
Clarity and consistency in quality testing
Supports global filings and inspections
Supports the complex supply chain
Facilitates the procurement process
Obstacles and Barriers 12
Willingness of pharmacopoeias/regulators/industry to changing the paradigm
Time and resources to achieve objectives
Overcoming past, history and tradition
Lack of trust “Not invented here” syndrome Lack of understanding of the issue
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Options for adopting Q4B
ChP or CNDA select to permit reference to USP/Ph
Eur/JP in submissions
Annexes comparing to PDG text
Assessment and comparison
Using the Q4B annexes and corresponding USP/Ph Eur/ JP Chapters Review each item in conjunction with the corresponding
ChP Chapter Identify any gaps Determine if the gaps can be closed by a revision to the
ChP If yes, prepare revision of ChP
Ideally indicating harmonised status with the other pharmacopoeia
If not, document why the differences in ChP must remain
Request a revision to the ICH Annexes to incorporate ChP / China information
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Multi-Compendial Acceptance
ChP and/or CNDA could choose to permit companies to align with either ChP / USP/ Ph. Eur / and /or JP
Recognising that all these compendia have valid robust, scientific processes for monograph/method/chapter development
Would demonstrate China’s leadership in Scientific, Quality & Risk based Thinking
China – Leading the way
China could be recognized as the world leader in convergence and harmonization
Accepting references to any of the major pharmacopoeias (ChP or JP or USP or Ph Eur)
China has a history of being more adaptable than other regions of the world
Seeking to prospectively and proactively harmonise new standards
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What does Industry need?17
Appropriate standards
Consistent with science- and risk-based approaches to development and manufacture of medicinesFlexibility to apply alternative or innovative technology and approaches
Streamlined review and approval of Regulatory SubmissionsAccepted standards allow focus on critical/novel aspects of submissionPharmacopoeia has important role within regulatory framework
Global Harmonisation
Avoid wasteful duplication of efforts for repeated tests
Evolution of the Pharmacopoeia
Effective processes for development and revision of monographs and general chapters