Wonder Journal of Pharmaceutical Policy and Practice 2013, 6:7

nations are not straightforward when there is an efficacy gain and a safety loss; such assessments are currently made on a case-by-case basis using expert value judg-ment. In diseases/conditions where there are many treat-ment options, a new medicine might be therapeutically Vitry et al. state that “stricter regulatory approval criteria would ensure better safety of the public”. They do not cite any examples where the safety of the Australian public has been compromised as a result of supposedly lax approval criteria by the TGA. The use of stricter criteria will result in the approval of fewer new medicines in Australia.interventions for patients with the disease/condition this has not occurred.Assessment of the therap medicines marketed in A Michael J Wonder I read with interest the study by Vitry et al. on the thera-peutic value of new medicines approved for marketin