People and the planet benefit from medicines which have the smallest possible impact on nature yet maintain the highest medical efficacy and safety standards. Our aim is to minimise the burden of our products on the planet and accelerate the delivery of sustainable, 零医疗. 为了实现这个目标, we follow the science to understand and address the environmental risks associated with our products.
其中一个风险是 环境中的药物, which is an unavoidable result of delivering life-changing medicines to patients. 药物主要通过患者的使用进入环境, 其中一些可以通过澳门第一赌城在线娱乐的身体进入水道. The Active Pharmaceutical Ingredients (APIs) found in our products are biologically active molecules which may interact with and impact wildlife and biodiversity when in the environment. We are committed to driving thought leadership and innovations to manage PIE. 作为行业的领头羊 PREMIER (which stands for Prioritisation and Risk Evaluation of Medicines in the EnviRonment), we are collaborating across our sector to develop tools to prioritise existing APIs in terms of their potential environmental risk and to identify environmental hazards of drugs in development. PREMIER is a six-year project started in September 2020 under the Innovative Health Initiative (IHI) -世界上最大的生命科学公私合作伙伴关系. It is co-ordinated by Radboud University and brings together a consortium of 27 public and private partners from the regulatory, 制药及研究界别(完整名单如下).
Since 2006, 作为药物授权的一部分, Environmental Risk Assessments (ERAs) have been required in Europe to determine the future long-term chronic risks of human medicinal products to the environment. However, 只有1左右的一小部分,对目前使用的900种产品进行了评估, 因为2006年之前批准的大多数药物缺乏完整的环境数据.
因此，PREMIER项目的主要目标是:
- Develop tools and models to identify potential environmental hazards and risks associated with APIs earlier in development
- 对2006年之前授权使用的遗留api进行筛选和优先排序
- 探索绿色药物设计的可行性和实用性
- 建立一个集中、透明的公共数据库和评估系统
Supported by the European Commission in partnership with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the project benefits from more than 10 million euros of investment to fund the research objectives. The PREMIER project specifically aims to address the following themes of the 欧洲战略方针 管理药品的环境风险;
- Explore the possibilities of developing pharmaceuticals which are lower risk for the environment
- Improve ERAs including via the 2019 Review (including a science-based catch-up system for APIs authorised prior to 2006)
- 扩大环境监测
- 解决25种重点药物的知识差距
PREMIER is tackling some very complex issues that are critical to better understand the risk of pharmaceuticals that reach the environment after patient use. We have already made great strides to develop better models to predict these risks, 优先考虑那些有关键信息缺口的人, 更好地理解澳门第一赌城在线娱乐将来如何设计更环保的药物, and identify what we could do to reduce the burden on laboratory animal studies.
迄今取得的成就
截至2024年年中，PREMIER拥有9家 出版物 在同行评议期刊上, covering key topics including greener pharmaceutical design and an approach to reduce animal testing and environmental fate modelling. 大约是项目的三分之一 可交付成果 也已经完成, and the focus is currently directed towards the remainder with more than 70 scientists and specialists working together on this programme. 其中一个关键部分将是公开和透明 可用的环境数据数据库 of pharmaceuticals, with the first release planned to be publicly available by the beginning of 2025.
联盟成员
该财团包括:
- 13家制药公司:澳门在线赌城娱乐, 和拜耳一起, BMS, 礼来公司, GSK, Haleon, Janssen, MSD, Novartis, Reckitt, Roche, 赛诺菲和施维雅.
- Regulatory community: The European Medicines Agency and the Dutch National Institute for Public Health and the Environment.
- 大学部门:埃克塞特大学, 哥德堡大学, 赫尔辛基大学, Leuphana大学, 内梅亨大学和约克大学.
- Research institutes: Swiss Federal Institute of Aquatic Science and Technology (EAWAG), 弗劳恩霍夫研究所和马里奥·内格里研究所.
- 三家小型企业:Ecologic、ECT和TEAM IT.
Our management of the risks associated with Pharmaceuticals in the Environment (PIE)
澳门第一赌城在线娱乐认识到, 即使浓度很低, 应确定与PIE相关的风险. 河流中痕量的药物, lakes, soils, 有时喝水, could potentially impact aquatic life from low-level and long-term exposure. Learn more about our industry-leading approach to effectively managing the risks associated with Pharmaceuticals in the Environment in our 派的声明.
The PREMIER project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 875508. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: The above communication reflects the Company's view and 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.
