The National Institute for Pharmaceutical Technology and Education (NIPTE), Inc., Minneapolis, Minnesota, 55414, USA.
Institute for Therapeutics Discovery and Development, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, 55414, USA.
AAPS PharmSciTech. 2020 May 24;21(5):153. doi: 10.1208/s12249-020-01718-9.
The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply chain to the USA is now a vital national security need. Reshoring the pharmaceutical supply with old know-how and outdated technologies that cause inherent unpredictability and adverse environmental impact will neither provide the security we seek nor will it be competitive and affordable. The challenge at hand is complex akin to redesigning systems, including corporate and public research and development, manufacturing, regulatory, and education ones. The US academic community must be engaged in progressing solutions needed to counter emergencies in the COVID-19 pandemic and in building new methods to reshore the pharmaceutical supply chain beyond the pandemic.
几十年来，向美国患者提供负担得起的高质量药品一直是当务之急。在 COVID-19 大流行期间和之后，这条关键路径变得曲折。为了恢复可靠性，将药品供应链回流到美国现在是一项至关重要的国家安全需求。用旧技术和过时技术回流药品供应链会导致固有的不可预测性和不良的环境影响，既不能提供我们所寻求的安全性，也不具有竞争力和可负担性。当前面临的挑战非常复杂，类似于重新设计系统，包括企业和公共研发、制造、监管和教育系统。美国学术界必须参与推进解决 COVID-19 大流行紧急情况所需的解决方案，并建立新方法，以在大流行之外回流药品供应链。
