Table 3.

Comparison of EMA and FDA TAGs with scientific guidelines for in vivo animal experiments

Guideline topic	Guidelines/authors	EMA		FDA
		No. of TAGs on topic	Preclinical guidance contained?	No. of TAGs on topic	Preclinical guidance contained?
Acute renal failure	Bellomo et al. (2004)	0	n.a.	0	n.a.
ALS	Ludolph et al. (2010) and Scott et al. (2008)	0	n.a.	0	n.a.
Alzheimer	Shineman et al. (2011)	1	n.a.	1	n.a.
Analgesic drugs	Rice et al. (2008)	1	n.a.	0	n.a.
Antiarthritic molecules	Bolon et al. (2010)	2	General	2	Specifica
Arrhythmia	Curtis et al. (2013)	1	Specific	0	n.a.
Brain injury	Margulies and Hicks (2009)	0	n.a.	0	n.a.
Chemoprevention	Verhagen et al. (2003) and Kelloff et al. (1994)	0	n.a.	0	n.a.
Drug‐eluting stents	Schwartz et al. (2008)	1	Specific	2	Specific
Endometriosis	Pullen et al. (2011)	0	n.a.	0	n.a.
Morbus Duchenne	Willmann et al. (2012) and Grounds et al. (2008)	1	Specific	1	General
Multiple sclerosis	Moreno et al. (2012)	1	n.a.	0	n.a.
Myocardial infarction	Bolli et al. (2004)	1	n.a.	0	n.a.
Rett syndrome	Katz et al. (2012)	0	n.a.	0	n.a.
Sepsis	Piper et al. (1996)	1	n.a.	0	n.a.
Stroke	Stroke Therapy Academic Industry Roundtable (STAIR) (1999), Macleod et al. (2009), Liu et al. (2009), Garcia‐Bonilla et al. (2011), Savitz et al. (2011) and US National Institutes of Health National Institute of Neurological Disorders and Stroke (2011)	1	n.a.	0	n.a.
TBC	Kamath et al. (2005)	0	n.a.	1	General
Total		11	General: 2 Specific: 3	7	General: 2 Specific: 2

^aOnly one of the two FDA TAG on antiarthritic molecules gives specific guidance.