From Historical Precedent to Modern Approvals: Lessons Learned

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One of the main challenges lies within the demarcation between medical devices and medicines. It is for the manufacturer to initially determine the classification regarding with regards to the primary function of a combination product. FDA and EMA guidance documents include definitions, and examples as well as laying out regulatory provisions for the manufacturer.

Secondly, depending on the regulatory pathway, various regulatory requirements need to be fulfilled for each component of the drug device combination with respect to preclinical testing, clinical investigation, manufacturing and quality control, adverse event reporting, promotion, advertising, and post approval changes.

Lastly, regional differences in regulatory requirements of combination products add another layer of complexity for product developers planning to launch combination products in multiple regions. These regional differences are yet unharmonized despite a few existing initiatives. As a whole, manufacturers in combination product space need good understanding and appreciation of regional regulatory considerations for successful submissions.