Regular marketing authorization	European Union: The marketing authorization procedure evaluates whether a medicinal product is efficacious and safe and whether it has the required pharmaceutical quality [16].
	United States: FDA approval of a drug indicates that data on the drug’s effects have been reviewed and that the drug is determined to provide benefits that outweigh its known and potential risks for the intended patient group [17].
Emergency use	European Union: EU member states can temporarily allow the marketing of an unauthorized medicinal product in emergency situations. Member states can decide that the requirements are less stringent than for a conditional marketing authorization [18].
	United States: The FDA may authorize unapproved medical products or unapproved uses during public health emergencies when no adequate and approved alternatives are available [19].
Conditional marketing authorization	This type of authorization is valid for one year and is awarded after an initial validation showing greater benefits than risks, on the condition that the new data is submitted as it becomes available [18].
Off-label use	This is the use of an approved drug for purposes for which it had not originally received regulatory approval [20].
Compassionate use	European Union: Compassionate use is the use of an unapproved drug that is given to a group of patients who have a disease that would result in severe disability or is life-threatening and cannot be satisfactorily treated with an approved drug [10].
	United States: Also called “expanded access”. It is an option for patients to get access to experimental drugs to treat life-threatening or serious health issues outside clinical trials when no satisfactory alternative treatment options are available [21].
Necessity as a justification for use	In German law § 34 StGB is often used to exculpate physicians who attempt to save lives through non-approved methods, including non-approved drugs, as long as they are reasonable to avert danger [22].