Trends, challenges and priorities

Combination products are an increasingly important element in drug life cycle management; however, they are subject to complex and rapidly evolving regulatory requirements. Technological advances, coupled with demand for reduced dosing and improved usability, are driving the development of more complex products such as bolus injectors for large volume delivery and combination products incorporating digital components. While these technologies have the potential to improve the patient experience, they also have significant implications for design development, verification and validation. Misalignment of these critical steps during the drug development process can lead to delays in late-stage clinical trials and regulatory submissions and examination, which ultimately increases the risk that patients do not benefit from the improved convenience and usability that these important products offer.

By working together, companies can pool their knowledge and real-world experiences to develop industry consensus approaches, which should lead to standardized approaches to combination product development and manufacturing, as well as harmonization of industry and regulatory expectations.

Members are actively engaged in the following workstreams.

  • European Union Medical Device Regulation (EU MDR) Article 117 Implementation: EU MDR article 117 came into effect in May 2021; however, there is no clear industry consensus regarding application to drug delivery devices, e.g. it is not clear if all drug-product contacting components must conform to invasive components requirements. The goal for this workstream is to develop an industry consensus approach for incorporating article 117 into development processes.
  • Essential performance requirements (EPRs) for device specification setting: there is no consensus view on how to interpret and apply EPR guidance. This means that licence holders and regulatory reviewers have significant freedom to interpret EPRs, which can lead to situations where regulatory agencies request additional EPRs in a submission that were not required for a previous molecule in the same delivery device. The goal for this workstream is to agree to a standard approach for the interpretation and classification of EPRs.
  • Post-launch Change Requirements workstream: The team are aiming to develop and document best practice approaches for managing variations in regional change requirements on post launch changes, particularly relating to drug delivery devices.
  • Human Factors: There is a lack of clarity around correct implementation of regulatory guidance, and best practice in Human Factors study design. Current guidance can be counter intuitive to good practice. The team aims to collect data from the industry that will show the current understanding across a range of topics affecting HF teams in the industry and to provide updated best practice guidance based on this data.

The following new workstream and pathfinder activities are also currently being mobilized:

  • Digital pathfinder: This new team will investigate opportunities for collaboration in two topic areas initially:
    • Demonstrating the value of the digital solution
    • Managing the impact of different regulatory requirements on URS, DIR, design verification/ validation plans
  • Medical Device sustainability: The Pathfinder is set to explore and expose what the key sustainability issues are, particularly related to drug delivery devices and how can the industry collaborate to efficiently and effectively address such issues.

MedTech deliverables June 2021- June 2022

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Milestones

EU MDR Article 117 implementation

Position paper published on implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements.

Essential Performance Requirements for device specification-setting

Presentation of interim comparison report on Essential Performance Requirements at Pre-Filled Syringes West Coast conference. Second chapter of report considering control strategies underway.

Human Factors deliverables

The Human Factors working group has issued a survey to collect data on the current understanding of a range of topics affecting Human Factors teams in the industry.
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