The Pharmaceutical InspectionCo-operation Scheme PIC/S has published a PIC/S Guide to Good Distribution Practice for Medicinal Products (PE 011-1). This Guide is based on the EUGDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely.
药品检查合作组织PIC/S日前公布了PIC/S的药品优良销售规范指南（PE 011-1）。该指南是依据欧盟GDP指南（2013/C 343/01）制订的，几乎完全引用了欧盟指南。
However, EU specific references have been deleted and the term "must" is often replaced by the term "should". A dedicated Responsible Person is not introduced by the PIC/S document. It talks about "designated responsible person(s)" or"designated person(s)". Chapter 2.2 "Responsible person" ofthe EU GDP Guide is not quoted in the PIC/S document.
当然，其中删除了欧盟专用的一些参考文献，采用“应”（SHOULD）替代了术语“必须”（MUST）。在PIC/S的文件中没有引入专用负责人的概念，而是采用了“被委任的负责人”或“被委任的人员”。欧盟GDP的第2.2章“负责人”在PIC/S的文件中并没有被引用。
Also import activities are covered by the PIC/S Guide. EU GDP Chapter 5.9 "Export to third countries" has been amended and also covers import activities. Chapter 10 "Specific provisions for brokers" has been deleted completely.
PIC/S指南中也包括了进口活动。它对欧盟GDP第5.9章“出口至第三国家”进行了增补，也包括了进口活动。第10章“中间商的特别条款”则被全部删除。
The structure of the PIC/S document has been aligned with the structure of the EU GMP Guidelines, including 9 chapters:
Chapter 1 Quality Management
Chapter 2 Personnel
Chapter 3 Premises and Equipment
Chapter 4 Documentation
Chapter 5 Operations
Chapter 6 Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
Chapter 7 Outsourced Activities
Chapter 8 Self-Inspections
Chapter 9 Transportation
PIC/S文件的结果在欧盟GDP指南的基础上进行了重排，共包括9个章节：
第1章 质量管理
第2章 人员
第3章 设施与设备
第4章 文件记录
第5章 操作运转
第6章 客诉、退货、疑似假药和药品召回
第7章 外包活动
第8章 自检
第9章 运输
As with the EU Guidelines, Risk Assessments will become a key tool for implementation of the new requirements.
与欧盟指南一样，风险评估将是实施新要求时的一个重要工具。
PE 011-1 is now an official PIC/S guidance document. This does not mean that it is automatically in force in all PIC/S member states. It is anon-binding guidance and PIC/S Participating Authorities need to decide whetherit should become a legally-binding standard and then implement it accordingly.Implementation should take into consideration national legislation. In some PIC/S countries for example, importation may fall under GMP and amanufacturer's license may be required.
PE 011-1现在已经正式生效，但这并不表示它就自动对所有PIC/S成员国产生效力。它是一份非强制的指南，参与PIC/S的国家药监局要决定是否将其变为法规强制的标准进行实施。实施时要考虑国家立法程序。例如，在有些PIC/S国家，进口可能是归属GMP管理，进口商需要持有生产许可。
Currently, PIC/S has 46 Participating Authorities, including most EU Member States, Switzerland, Japan and the USA.
目前，PIC/S拥有46个成员国，包括了大多数的欧盟成员国、瑞士、日本和美国。
