2015年5月29日，FDA发布了指南草案《已建立的条件： 已获批的药品、生物制品需要报告的CMC变更》（Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products）。定义了术语：已建立的条件（Established Conditions，EC）。
FDA没有使用美国医药研究与制造商协会（PhRMA）推荐的术语——监管承诺（Regulatory Commitments），认为它是混淆的。EC 一词源自法规21 CFR 314.70(a)(1)(i)。涉及“批准后变更”、“药品生命周期”等话题，美国的行业协会、监管方在持续探讨，ICH Q12也有讨论。ICH Q12 名为“药品生命周期管理的技术和监管考虑（Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management）“，该指南尚处于专家协商阶段（Step 1），其概念文件（concept paper）和业务计划（business plan），于2014年9月获得ICH协调委员会通过。
Definition of Established Conditions
FDA defines established conditions as the description of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy, as defined in an application, that assure process performance and quality of an approved product. Changes to the established conditions must be reported to FDA (21 CFR 314.70 and 601.12).
[3] 2015年1月，CDER的药品质量办公室（Office of Pharmaceutical Quality ,OPQ）成立，其药品生命周期办公室（Office of Lifecycle Drug Products）肩负从生命周期方面统一原研药、仿制药的质量，管理批准后补充申请等职责。现在是合适的时机来讨论改进药品生命周期的管理。【FDA Official Says Time is Right for Exploring 'Regulatory Commitments' for Post-Approval Changes , pink sheet, May 28 2015】
参考资料：
Industry's 'Regulatory Commitments' Concept Draws FDA's Interest, pink sheet, September 29 2014.
FDA Official Says Time is Right for Exploring 'Regulatory Commitments' for Post-Approval Changes , pink sheet, May 28 2015.
FDA Would Establish Conditions for Swift Manufacturing Changes, pink sheet, June 25 2015. Daniel Y. Peng's Presentation at FDA/PQRI Conference (September 17, 2014)
