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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

JANEEN.SKUTNIKWILKINSON@BIOGEN.COM