Fed Regist. 2011 Apr 13;76(71):20513-8.
The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
美国食品药品监督管理局（FDA）正在修订生物制品法规，以允许生物制品评估和研究中心（CBER）主任或药品评估和研究中心（CDER）主任在适当时批准成分材料法规的例外情况或替代方案。当为支持此类请求而提交的数据证明生物制品在所寻求批准的使用条件（包括适应症和患者群体）下的安全性、纯度和效力时，对例外情况或替代方案的请求将被考虑批准。FDA采取这一行动是因为根据《公共卫生服务法》（PHS法）许可的安全、纯净和有效的生物制品在开发和制造方面取得了进展，在某些情况下，现行的成分材料法规过于规定性且限制过多。本规则为生物制品制造商提供了灵活性，以便在适当的时候采用现有的科学技术进展，同时不削弱公共卫生保护。
