LifeCycle Management of Drug Products: Industry Perspective. Dawn Culp VP, Global Regulatory Affairs Policy, Mylan

1 LifeCycle Management of Drug Products: Industry Perspective Dawn Culp VP, Global Regulatory Affairs Policy, Mylan The views presented here today...
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LifeCycle Management of Drug Products: Industry Perspective Dawn Culp VP, Global Regulatory Affairs Policy, Mylan

The views presented here today are those of the presenter and do not necessarily reflect those of Mylan or the GPhA.

ICH Q12 – What? • Q12 is a continuation of the Q8, Q9, Q10, and Q11 set of ICH Quality Guidelines and will apply to pharmaceutical products (chemical and biological) Q8 Pharmaceutical Development

Q9 Quality Risk Management

Q10 Pharmaceutical Quality System

Q11 Development and Manufacture of Drug Substances

Q12 Pharmaceutical Lifecycle Management

• This lifecycle management guidance will provide clarity around regulatory commitments in the dossier and how manufacturers can more efficiently implement post-approval manufacturing changes • It will provide a framework to facilitate the management of postapproval CMC changes in a more predictable manner

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ICH Q12 – Why? • There is no harmonized approach on technical and regulatory considerations for lifecycle management • While Q8 – Q11 provide opportunities for a more science and risk-based approach for assessing changes, several gaps exist which limit the full realization of the intended benefits • Post-approval “operational flexibility” envisioned by Q8 – Q11 has not been achieved • Inconsistent utilization of post-approval change management plans and comparability protocols • To date, ICH has focused on the early stages of the product lifecycle (development to launch). A similar focus is needed for the commercial manufacturing phase to fill the gaps and fully realize the opportunities promised by ICH Q8 – Q11 • Industry, regulators and patients will benefit from a reliable supply of high quality products

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ICH Q12 – How?

• Develop a harmonized approach to “regulatory commitments”

• Delineate the appropriate level of detail and information necessary for regulatory assessment and inspection in the dossier • Establish criteria for a harmonized risk-based change management system • Establish criteria for post-approval change management protocols for proactively defined post-approval changes

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ICH Q12 – Who? Expert Working Group Rapporteur: Moheb Nasr (GSK) Co-Rapporteur: Ashley Boam (FDA)

Industry

Regulators

PhRMA

EFPIA

FDA

EMA

JPMA

BIO

PMDA

Canada

EFCG

IGPA

Switzerland

Taiwan

Singapore

USA (Perrigo) USA / India (Dr. Reddy’s Labs) EU (Mylan) Japan (Towa Pharmaceuticals)

Switzerland Small internal working group

ICH Q12 – When & Where? Past: June 2014:

Adoption of topic by approval of ICH Steering Committee to develop concept paper

July 2014:

Agreement of concept paper and business plan by IQDG

Sept 2014:

Adoption of concept paper and business plan by Steering Committee

Nov 2014:

1st EWG Meeting (Lisbon, Portugal)

June 2015:

2nd EWG Meeting (Japan)

Future: Nov 2015:

3rd EWG Meeting (USA)

Q2 2016:

Adoption of Step 2 Document

Q2 2017:

Adoption of Step 4 Document

ICH Q12 – Progress to Date Since the first meeting: • The EWG has broken out into 3 regional working groups to address unique regional issues North America

Europe

Asia

• The EWG has also broken out into 4 drafting teams to work on writing the 4 sections of the guideline Regulatory Commitments

Knowledge Management

Change Management Post-Approval Change Management Plan (PACMP)

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Drafting Team #1 - Regulatory Commitments • Regulatory commitments define the binding information concerning the manufacture and control of a pharmaceutical product • They are proposed by the manufacturer and approved by the health authority • They can provide the basis for applying appropriate regulatory mechanisms for management of changes to a product and its associated manufacture and control through the lifecycle • The definition of these commitments will enable the determination of the level of regulatory submission/notification, if any, for post-approval changes; and the supportive information to be included in the regulatory dossier to facilitate assessment and inspection without increasing requirements

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Drafting Team #2 – Knowledge Management • The foundation of managing products is the management of the knowledge acquired throughout the lifecycle of the product • Will focus on the utilization of knowledge, within a firm’s PQS, to enhance clarity and to enhance communication within firms and transparency with regulators (both assessors and inspectors)

• Knowledge management is defined in ICH Q10 as a systematic approach to acquiring, analyzing, storing, and disseminating information; however, from a practical standpoint, ICH Q12 will build upon this definition so that the knowledge gained over the product lifecycle can be effectively used within the industry and communicated to the regulators

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Drafting Team #3 – Change Management

• Quality risk management should be utilized to evaluate proposed changes; and the level of effort and formality of the evaluation should be commensurate with the level of risk • Take the principles from ICH Q9 and Q10 to provide a framework for an adaptive/risk-based approach to change, where adaptive means proportional to the “criticality” of the change

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Drafting Team #4 – Post-Approval Change Management Plan (PACMP) • A PACMP is a regulatory submission or a section of a submission that facilitates manufacturers’ ability to implement manufacturing changes and improvements without further regulatory submission; and enhances the regulators’ understanding of the manufacturers’ change management and quality processes • The integration of the PACMP into the development of an overall lifecycle management plan will be further discussed by the ICH Q12 EWG

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Product Lifecycle Management – Industry Perspective

• Quality is not a department, it is a state of mind (culture) • ICH Q12 is not about making things “easier” for us, it’s about doing things right; and should facilitate the opportunities for a risk-based approach with responsibility and accountability on the manufacturers (“own the process”)

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Idea Ongoing Manufacturing

Development

Quality Launch

Filing

Validation

Tech Transfer

Product Lifecycle Management – Industry Perspective • The health authorities don’t set the bar, they set the floor • Technology, globalization and consumerism are constantly changing and the regulatory environment needs to keep up

• It’s not what you know, it’s what you do with what you know when you know it

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ICH Q12 – Generic Industry Position

Goals

Greater opportunities for innovation and continued improvement

Increased industry responsibility for quality and a reliable supply of product

Decreased burden on regulators and a better understanding of company Pharmaceutical Quality System (PQS) for management of post-approval CMC changes (increased confidence)

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ICH Q12 – Generic Industry Position (continued) •

How? (1)

Regulatory Commitments a) Focus on factors that are directly related to product performance i. API and FP Specifications ii. Control Strategy (as opposed to tactics) iii. Commitments that ensure continued quality in the face of change (greater reliance on quality systems) iv. Goal is to establish process-independent quality standards

(2) Broad Post-Approval Change Management Plans (PACMP’s)

a) b)

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Reflect back to Regulatory Commitments i. Changes that don’t impact regulatory commitments don’t need PACMP’s Limited value to using PACMP’s for individual changes i. For Industry » Requires 2 steps (PAS + 2nd submission) » Requires separate PACMP’s for each change event ii. For Regulators » Additional workload (due to 2-step process) » Requires review of separate PACMP’s for multiple changes

ICH Q12 – References

• Final Concept Paper Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014. Endorsed by the ICH Steering Committee on 9 September 2014. • Final Business Plan Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014. Endorsed by the ICH Steering Committee on 9 September 2014.

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