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, 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.
All nine member companies are actively engaged in the following workstreams.
- 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 confirm 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.
The following new workstream and pathfinder activities are also currently being mobilized:
- Post-launch change requirements workstream – this new team will focus on best practice approaches for managing variations in regional change requirements on post launch changes
- Human Factors pathfinder – this new team will facilitate knowledge exchange and explore opportunities for best practice approaches across a range of topics, including regulatory guidance implementation, study design and participant training
- 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 input report), design verification/ validation plans
MedTech deliverables 2021
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EU MDR Article 117 implementation
The team conducted a benchmark survey in Q2, 2021 to understand how companies are currently working with key elements of article 117, including documentation requirements for Notified Body Opinion review, application of General Safety and Performance Requirements to device components and strategies for determining substantial post approval changes. The results of the survey have been incorporated into a position paper which will describe MedTech member experiences and concerns when working with article 117. The position paper is due to be published by end of Q4, 2021.
The team is also preparing to write an Article 117 implementation good Practice guide to help companies to streamline their device submission processes. This guide is due to be published by the end of Q2, 2022.
Essential Performance Requirements 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.
The team has been investigating how company approaches differ when it comes to the application of Essential Performance Requirements (FDA) to injectable combination products. A report outlining the team’s observations is due to be published in Q1, 2022.
In addition, the team is planning to produce a BioPhorum response to FDA’s pending draft EPR guideline.