AstraZeneca is leading a new 6-year project with the Innovative 药物 Initiative (IMI), focused on the Prioritisation 和 Risk Evaluation of 药物 in the EnviRonment (PREMIER).
The IMI is a public-private partnership between pharmaceutical companies, the European Commission 和 the European Federation of Pharmaceutical Industries 和 Associations (EFPIA). Following the success of the 5-year IMI project Intelligent Assessment of 环境中的药物 (iPIE), 2019年6月结束, 澳门葡京赌博游戏将于2020年9月1日启动PREMIER项目.
由澳门葡京网赌游戏和内梅亨大学领导, 与其他九家制药公司(拜耳, 百时美施贵宝, 礼来公司, 葛兰素史克公司, 默沙东公司, 诺华制药, 罗氏公司, 赛诺菲和施维雅), 欧洲药品管理局, nine other research institutes (Dutch National Institute for Public Health 和 the Environment, 埃克塞特大学, 作者之一, 弗劳恩霍夫研究所, 哥德堡大学, 赫尔辛基大学, Leuphana大学, Mario Negri Institute 和 the University of York) 和 four Small Medium Enterprises (Ecologic, 等, 模拟组学和团队IT), the project aims to deliver an innovative framework for characterising the environmental risks of active pharmaceutical ingredients (APIs), Which可以用来:
- Develop tools 和 models to identify potential environmental hazards 和 risks associated with APIs earlier in development
- Screen 和 prioritise legacy APIs authorised for use prior to 2006 for a tailored environmental assessment
- 探索绿色药物设计的可行性和实用性
- Make environmental data on APIs more visible 和 accessible to all stakeholders
欧盟委员会支持, the project benefits from €10 million investment to fund the research objectives. The PREMIER project specific aims to address the following themes of the 欧洲战略方针 管理药品的环境风险;
- Support the development of pharmaceuticals which are less harmful for the environment 和 promote greener manufacturing
- Improve environmental risk assessments (ERAs) 和 its review (including a science-based catch-up system for APIs authorised prior to 2006)
- 扩大环境监测
- 填补其他知识空白，减少2006年以前药物的数据空白
The IMI PREMIER project is another example of how we are leading the way in environmental protection 和 mitigating the risk of pharmaceuticals in the environment. Investing in this project will allow us to assess 和 reduce the environmental risk of our products so we can continue to deliver medicines to patients, 不损害澳门葡京赌博游戏对可持续发展的承诺.
澳门葡京赌博游戏如何减轻与原料药有关的环境风险
作为一家负责任的医疗保健公司, 澳门葡京赌博游戏致力于社会和地球的健康和安全. 澳门葡京赌博游戏把有效管理与之相关的风险作为首要任务 环境中的药物 (派).
Pharmaceuticals enter the environmental mainly as a result of patient use, 它们在哪里可以通过澳门葡京赌博游戏的身体进入水道. Drug manufacturing 和 the improper disposal of unused medicines also add to the trace levels of pharmaceuticals in rivers, 湖泊, 土壤, 和, 有时, 饮用水, 从而将api发布到环境中. Some pharmaceuticals have been implicated in potential impacts on aquatic life from low-level 和 long-term exposure.
大约有1个,900个api正在使用, yet the environmental risks of only a small proportion of these has been assessed. In 2006, the requirement for Environmental Risk Assessments (ERAs) came into force in Europe requiring the long-term chronic risks of human medicinal products to be determined as part of their authorisation; many drugs approved prior to 2006 lack complete environmental risk assessment data. This has resulted in an urgent need to develop pragmatic approaches for prioritising existing APIs in terms of potential environmental risk 和 for identifying environmental hazards of drugs in development.
由于高流失率, the ERA for pharmaceuticals is typically conducted late in pharmaceutical development; in many cases these environmental studies are conducted in parallel to Phase III clinical trials. It is envisaged that the tools developed by PREMIER will enable environmental consideration to be integrated earlier within the drug development process.
以及技术目标, 比如预测未来药物的危害和环境风险, the PREMIER project aims to improve governance 和 data transparency across the industry. 除了, PREMIER提供了一个建立网络和伙伴关系的机会, bringing together those who have an interest in green drug development 和 innovative medicine.
This project has received funding from the Innovative 药物 Initiative 2 Joint Undertaking under grant agreement No 875508. This Joint Undertaking receives support from the European Union’s Horizon 2020 research 和 innovation programme 和 EFPIA.
Disclaimer: The above communication reflects the author's view 和 neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
