Combination product QMS requirements for pharma companies entering the EU market

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The global market for drug-device combination products is booming; it was valued at $118.13 billion in 2021 and is expected to expand at a compound annual growth rate of 8.8% by 2030. To capture the growing market with minimal business disruption, most pharma companies used to rely on third parties to develop and obtain the regulatory approval for the device in a combination product, a product that combines a medicinal product or substance and a medical device in a single integral unit (e.g., prefilled syringes).

However, pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties when ensuring the safety and efficacy of the combination product. Therefore, pharma companies have begun to expand their quality management systems (QMS) to allow them to become the legal manufacturer of the medical device components of their combination products.

A QMS is a structured system that includes policies, processes, and procedural documents that a pharmaceutical or medical device manufacturer has in place throughout the product’s life cycle. Implementing a QMS that supports medical devices is an essential step in building the new capabilities and becoming a legal manufacturer of such devices.

This will also enable pharma companies to manufacture personalized treatments that maximize positive health outcomes and system resilience, which is a market that will increase by $70 billion to $390.4 billion by 2030. In this article we discuss the challenges and considerations for companies that are interested in entering the EU market with combination products.