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Janis Bernat

Director, Scientific & Regulatory Affairs

IFPMA

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Regulatory Challenges & Need for Collaboration

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Definition of Regulatory Reliance

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Regulatory reliance (RR) is the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision.

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The relying authority remains independent, responsible and accountable regarding the decisions taken, even when it relies on the decisions and information of others.

The Good reliance practices in the regulation of medical products1 released by the World Health Organization (WHO) adopted the following definition:

1 Refer to Annex 10 of the Fifty-fifth report of WHO Expert Committee on Specifications for Pharmaceutical Preparations: (TRS 1033)

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Level of collaboration/reliance among regulatory agencies

Improving efficiency

Building trust towards establishment of equivalence

Mutual Recognition

Unilateral Recognition

Regional reliance mechanisms

Work-sharing including joint activities

Abridge pathways using reliance

Standard processes

Increasing level of reliance

No level of reliance applied

Reliance

Recognition

Different levels of collaboration/reliance among NRAs are possible when implementing regulatory reliance

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Processes where regulatory reliance is applied to :

Registration and marketing authorization

Clinical trials oversight

Post-approval changes

Regulatory inspection

Vigilance

NRA lot release

Laboratory testing

Market surveillance and control

Pre- and post-approval processes

Pre-approval processes

Post-approval processes

The full life cycle of medical products can be covered through the application of regulatory reliance, with the exception of a few regulatory activities1

1 Some examples of these include local adverse event monitoring, national labelling and product information activities, and approval of locally manufactured products

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Overview of the enablers of regulatory reliance

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REGULATORY RELIANCE

Trust

Convergence and harmonization

Information-sharing and dialogue/ effective communication between regulators

Economic or legal integration

Engagement of stakeholders

Enablers of regulatory reliance commonly discussed include:

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Role of key stakeholders in regulatory reliance

ROLE OF STAKEHOLDER

A variety of stakeholders form part of the regulatory reliance environment

Regulatory authorities

(e.g., NRAs, Ministries of Health, National Health Institutes)

Intergovernmental organizations

Governments

Professional associations or societies (e.g., medical, regulation, health economics)

Research institutes, universities, or think tanks

Other organizations, including non-governmental and patient organizations and foundations

  • Outline principles for the practice of regulatory reliance
  • Provide recommendations for its application
  • Assist countries in capacity building and recommendation implementation
  • Apply recommendations for the application of regulatory reliance at a national level
  • Create and participate in networks of stakeholders for regulatory reliance
  • Support other regulatory agencies in the implementation of regulatory reliance
  • Prioritize regulatory reliance to improved medicine availability
  • Develop policies that facilitate implementation of regulatory reliance at a national level
  • Negotiate binding mutual agreements or treaties with other governmental bodies
  • Provide evidence of benefit of regulatory reliance
  • Participate in alliances and networks in support of and advocate for regulatory reliance
  • Perform research and develop evidence on the necessity and effects on regulatory reliance
  • Promote and participate in alliances and networks in support of and advocate for regulatory reliance

Industry

  • Participate in conversations that bring up the need for regulatory reliance
  • Promote and participate in alliances and networks in support of and advocate for regulatory reliance

Decision makers

Influencers

Other key groups

  • Supports regulatory reliance and provides feedback on guidelines and implementation
  • Promotes alliances and supports advocates

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IFPMA Engagement- Regulatory Reliance TF

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        • Generate additional resources (i.e. reports, key messages, case studies...) that illustrate industry's positions on importance of reliance
        • Foster the progress of discussions happening at global and regional level on reliance through participation in key meetings and events and collaborations with sister associations
        • Participate in the creation of awareness about the importance of reliance and provide the tools necessary for the inclusion of reliance in advocacy plans

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Regulatory Reliance | The Role of Patients?

Regulatory reliance (RR) can represent a valuable tool to accelerate registration of and access to medicines and other key medical technologies for vulnerable groups.

Patients need to get involved to ensure the perspectives of civil society are heard and should be fostered through participation in information-sharing and training programs.

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Regulatory Reliance | Multiple advantages

Patients & Healthcare Providers

Timely access to safe, effective and quality medical products.

All stakeholders impacted by regulatory systems have the potential of benefiting from Regulatory Reliance

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Regulatory Agencies

Manufacturers

Efficient utilization of resources by avoiding duplication of work and providing opportunities to strengthen the regulatory system, while maintaining sovereignty over decision-making.

Streamlined management of regulatory submissions and global supply systems as well as predictable, timely approvals.

How to implement it?

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Best practices?

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IFPMA Position Paper on Regulatory Reliance

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(link)

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Conclusion

  • Reliance can accelerate access to innovative medicines

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  • Patient involvement will foster implementation of regulatory reliance.

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  • Co-creation towards reliance is key

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  • Regulatory reliance supports capability building

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IFPMA engagement- Following events

      • IFPMA IAPO Engagement on Reliance
        • Workshop “Regulatory systems strengthening & regulatory reliance – Key elements for a holistic approach to patients’ advocacy”- Train the Trainer Concept
        • Planned for September 2023

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IFPMA engagement- Following events

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Thank you

Q&A and feedback

  • Janis Bernat
    • J.bernat@ifpma.org

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IFPMA’s position paper on regulatory reliance

/company/ifpma

@ifpma

Contact us

ifpma.org

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