Combined Product Development Challenges

What are Combined Products and their status in the EU?

The development of science and technology is advancing increasingly rapidly, leading to important innovations in treatments. Currently, 20% of approved medicinal products are combination (CP), incorporating medicine and a medical device [1]. The European Union (EU) deals with CP by separating the different components of the product, which are governed by different regulations [2]. However, the EU doesn’t provide an integrated approach for their assessment, although they represent more than 1 in 5 of the current products in development [3]. Therefore, to support the development of increasingly complex medicines that increasingly incorporate technologies in Europe, the European Medicines Agency (EMA) has launched the Regulatory Science to 2025 strategy to build a more adaptive regulatory system and encourage innovation. According to this plan, gaining insight into innovation on drug-device combination (DDC) products via horizon scanning is an action that should be followed to create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products (first goal of the strategy) [4].

The future of the existing Guidelines

Moreover, due to the complexity of CP guidelines, some non-legally binding guidelines are used by manufacturers, such as “Guideline on the quality documentation for medicinal products when used with a medical device” that was published by EMA in 2021 and the MEDDEV 2.1/3 rev.3 guidance document. This EMA guideline has highlighted the impossibility of covering all types of devices and/ or future technologies that may be used on CP. If DDC incorporates any new emerging technology, EMA recommends that applicants contact the competent authorities and notified bodies. This raises the need for more complex scientific assessments as companies need new ways of integrating novel CP, device/drug, biologic/device or drug/device/biologic development methods, regulatory requirements, and competency in key individuals heading the projects.

What can PLG do to support you?

The active nature of the medical industry’s drug, device and biological spaces combined with the ever-evolving technological advancements produces more complex products. It is imperative for your company to keep up and stay ahead of the curve and to have a partner as dynamic as the industry itself to do so.

ProductLife Group has dedicated resources to support MedTech with CP and DDCs. Trust us regarding Global Strategy and Device Qualification to Due Diligence of your Technical File.  We cover Compliance, the new regulations for AI as a Medical Device (AIaMD), and ethics for AI. Of course, as for your combinations’ pharma/biological parts, we include Pre-Clinical and Clinical Study Management, Clinical and Performance Evaluations. A full range of regulatory, pharmacovigilance and life cycle maintenance services.

We have a full range of experts dedicated to regulatory and social evolutions to be at the forefront of technology and regulatory science innovations. We also work with collaborative public-funded projects. This allows PLG to support start-up companies and mature ones alike.

Contact us to learn more about our services and see how we can support your growth.

References:

1. https://www.efpia.eu/media/677176/efpia_blogcollection_final.pdf
2. https://www.frontiersin.org/articles/10.3389/fmed.2022.821094/full
3. https://www.efpia.eu/media/677176/efpia_blogcollection_final.pdf
4. https://www.ema.europa.eu/en/documents/report/emas-regulatory-science-strategy-2025-mid-point-achievements-end-2022_en.pdf