Table 1.

The Definition of combination products in the U.S., China and Japan.

Nation	Name	Definition
United States	Combination products	“A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.” [31]
China	Drug/device combination products	“A product made up of drugs and medical devices and produced as a single entity.” [43]
Japan	Combination products	“The products marketed as a single drug, medical device, or cellular and tissue-based product that combine two or more types of drug, device, processed cell, etc. that are expected to fall under the category of drugs, medical devices, or cellular and tissue-based products if marketed individually.” [46]