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5 key considerations for combination product regulations


07/02/2019

The market for combination products is rapidly expanding, this could be attributed to the rising frequency of chronic disease such as diabetes, cardiovascular disease and treatment of allergies. These products are advancing medical care and will likely have a significant impact on the industry in the coming years. The market for these products is earmarked for growth with sources stating that the industry is likely to hit US $115 billion by 2019.

Pharma IQ sat down with Audrey Clarembeaux, Head of Medical Device Development QA at UCB to discuss the key considerations that need to be made when ensuring regulatory compliance in combination products.

1. Optimise harmonisation between the two partners

“A biologic-device combination product is a marriage between two partners with cultural differences” (Anderson, Liu and Subramony, AstraZeneca). Clarembeux describes combination product regulations as “two worlds coming together”. It is the unique nature of these products that creates such challenges in defining their specific regulatory requirements. 

Although there has been “admirable cooperation” between the industry and FDA in recent years, it remains the responsibility of the manufacturer to comply with relevant regulations. They must ensure the development of good business practises that meet FDA rules while aligning with a company’s existing quality system. 

There is also no specific type of marketing application for combination products and the market is hindered by stringent government and FDA regulations. Companies should not need to reinvent the wheel to integrate combination products into their portfolio, but a review of processes, governance and technology is required in order to comply with regulations.

2. Understand which regulatory pathway your product should take

It is challenging to decide which pathway is appropriate for combination products due to their two independently regulated elements; their nature means a ‘one-size-fits-all’ approach is unlikely to be an effective approach to regulations. 

The FDA recognises three different ways that products can be combined to meet the definition of a combination product. These are: physically combined products for example a drug-eluting stent, products that are packaged together such as a drug-vial with an injector pen, and products labelled specifically for use together such as a photodynamic therapy drug packaged with an activating light source.

 In addition to the category of combination product, it is important to establish the primary mode of action to define which regulatory pathway a combination product should take. Drug combination products, device combination products and biological combination products each have their own regulatory pathways and a unique set of regulatory requirements. This adds an additional layer to the regulatory pathway

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