Abstract
With the increases in drugs for rare diseases and other modalities than small molecule drugs, circumstance surrounding ERA for human pharmaceuticals is changing.
From quantitative viewpoints on environmental exposure levels, considering industry trends and surveys by the JPMA, environmental exposure of original (non-generic) drugs will decrease due to shift of drug targets from diseases with large patient populations to orphan diseases and patent expiration of original drugs developed for large populations. From qualitative viewpoints on hazard, the wide variety of modalities may make pharmaceutical ERA more diverse and complex.
Most of indications for new modalities are rare diseases at present and ERA in new modalities seem to be less important because environmental emissions are considered limited. However, when a new modality is targeted towards diseases with large patient populations, it may be necessary to verify if the current flowcharts can be applied for the new modality because the current flowcharts had been established during the era when small molecule drugs dominated and may not be well optimized for new modalities. Furthermore, evaluation of viral shedding to environment is mandatory in gene therapy products using viral vectors regardless of quantitative viewpoints such as environmental exposure level based on patient population, unlike small molecule drugs.
ERA is an essential process not only from the perspective of environmental sustainability but from the perspective of the sustainabilities of human pharmaceuticals and pharmaceutical industries.
