加强欧盟和美国医药检查方面的合作 - 药群论坛

The European Commissionfile:///C:/Users/ADMINI~1/AppData/Local/Temp/msohtmlclip1/01/clip_image001.gif (EC), the UnitedStates (US) Food and Drug Administration (FDA) and theEuropean Medicines Agency (EMA) have signed a new confidentiality commitmentthat allows the US regulator to share non-public and commerciallyconfidential information, including trade secret informationrelating to medicine inspecti** with EU regulators. This confidentialitycommitment is a milestone in the ongoing implementation of the mutual recognition of inspecti** of medicine manufacturers and it aims tostrengthen the EU-US relati**hip. Ultimately it will contribute to a moreefficient use of inspection resources by regulators for the protection of humanand animal health.

欧盟委员会、美国FDA和欧洲药品管理局之间签署了一项新的保密承诺，允许美国监管机构将非公开和商业机密信息（包药品检查的贸易保密信息）共享给欧盟监管机构。该保密承诺是正在实施的“药品制造商检查互认”的一个里程碑，旨在加强欧盟和美国之间的关系。最终，它将有助于监管机构更有效地利用检查资源保护人类和动物的健康。

The EU and the UShave had confidentiality arrangements in place since 2003, allowing for theexchange of confidential information as part of their regulatory and scientificprocesses. However, complete exchange of information was not possible underthese arrangements.

The newconfidentiality commitment formally recognises that FDA's EU counterparts havethe authority and dem**trated ability to protect the relevant information.This step now allows the sharing of full inspection reports, allowingregulators to make decisi** based on findings in each other’s inspectionreports and to make better use of their inspection resources to focus onmanufacturing sites of higher risk.

新的保密承诺正式承认，美国食品和药物管理局的欧盟同行有权并有能力保护相关信息。现在，这一步骤允许共享完整的检查报告，允许监管机构根据彼此检查报告中的发现做出决策，以及更好地利用他们的检查资源来将关注重点放在高风险的生产场所上。