Abstract Current environmental research focuses extensively on pharmaceutical waste, demonstrating the contamination caused by active pharmaceutical ingredients. Regulations and programs to evaluate, prevent, and reduce environmental risks linked to human medicines are currently being developed in various countries. We assessed the Romanian legislation to identify the potential areas of development of environmental protection policies in the pharmaceutical field. Laws and regulations of interest were selected, and their relevant provisions were analysed using methods of legal interpretation, then corelated with their equivalent in more developed countries. Romanian legislation requires an evaluation of the environmental impact of human medicines, an assessment of non-clinical research and pharmaceutical manufacturing projects, appropriate management of pharmaceutical waste and its disposal on a contract basis, and the collection and disposal of expired or unused medicines by pharmacies. In practice, however, a coherent system for pharmaceutical waste management is lacking because of many legal loopholes in environmental protection. Romanian legislation does not include specific rules regarding sound environmental practice for clinical research laboratories, pharmaceutical manufacturers, and wholesale distributors. The pharmaceutical industry has no legal responsibility to manage and dispose expired or unused medicines collected from the population. Equitable sharing of environmental responsibility by the pharmaceutical industry actors along with the involvement of public authorities should be established via legislation and regulation that reflect the requirements mandated by other more advanced countries. Additionally, continuous training programs should be provided for practitioners to reinforce their role in the rational use of medicines and professional campaigns should be created to raise public awareness about preventing environmental contamination.

中文翻译：

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罗马尼亚与人类药物相关的活动：法律环境保护问题

摘要 当前的环境研究广泛关注药物废物，证明活性药物成分造成的污染。目前，各国正在制定评估、预防和减少与人类药物相关的环境风险的法规和计划。我们评估了罗马尼亚的立法，以确定制药领域环境保护政策的潜在发展领域。选取感兴趣的法律法规，采用法律解释的方法对其相关规定进行分析，然后与较发达国家的同类法律法规进行对比。罗马尼亚立法要求评估人类药物对环境的影响，评估非临床研究和药物制造项目，药物废物的适当管理及其在合同基础上的处置，以及药房对过期或未使用的药物的收集和处置。然而，在实践中，由于环境保护方面的许多法律漏洞，缺乏一个连贯的药物废物管理系统。罗马尼亚立法不包括关于临床研究实验室、药品制造商和批发分销商的良好环境实践的具体规则。制药业没有管理和处置从人群中收集的过期或未使用的药物的法律责任。应通过反映其他更先进国家强制要求的立法和法规，建立制药行业参与者公平分担环境责任以及公共当局的参与。此外，应为从业者提供持续的培训计划，以加强他们在合理用药方面的作用，并应开展专业运动，以提高公众对预防环境污染的认识。