Table. Measures taken by selected regulatory agencies before and after licensing to assess and control antimicrobial drug resistance*.

Measure	Australia	France	European Commission	United States
Primary drug registration body	Therapeutic Goods Administration, Australian Drug Evaluation Committee	AFSSAPS (French health products safety agency), Commission for Marketing Authorization	European Medicines Evaluation Agency†	Food and Drug Administration‡
Drug resistance advisory resource	EAGAR	GTA, CA-SFM, ONERBA	EARSS	AIDAC
Licensing
	Use of supportive PK/PD data	Yes	Yes	Yes	Yes
	Risk assessment	Yes	Yes	Yes	Yes
After licensing
	Prescription-only status	Yes	Yes	NA	Yes
	Community drug subsidy restrictions	Yes	No	NA	No
	Participation in education (e.g., guidelines)	Yes	Yes	No	Yes
	Directives on drug use	Yes	Yes	No	No
	Indication review based on resistance	No§	Yes	Yes	Yes
	SPC update/harmonization	Yes¶	Yes	Yes	Yes

*AFSSAPS, Agence Française de Sécurité Sanitaire des Produits de Santé; EAGAR, Expert Advisory Group on Antimicrobial Resistance; GTA, Groupe de Travail Anti-infectieux; CA-SFM, Comité de l'Antibiogramme de la Société Française de Microbiologie; ONERBA, Observatoire National de l'Epidémiologie de la Résistance Bactérienne aux Antibiotiques; EARSS, European Antimicrobial Resistance Surveillance System; AIDAC, Anti-Infective Drugs Advisory Committee; PK/PD, pharmacokinetic/pharmacodynamic; NA, not applicable; SPC, summary of product characteristics.
†Scientific opinions are prepared by committees for human medicinal products, veterinary products, and orphan products.
‡Wider issues involving drug resistance, such as surveillance and appropriate use, are the purview of a number of United States agencies, including the Food and Drug Administration but also the Centers for Disease Control and Prevention, the National Institutes of Health, and other agencies partnering in the United States Public Health Action Plan to Combat Antimicrobial Resistance initiated in 2001 (2).
§Only possible for animal antimicrobial drugs.
¶Agreement has been made to update SPCs every 5 years with Australian surveillance data. However, a mechanism for collecting these data has yet to be agreed upon.