20150218 ECA新闻：供应链：一系列的新法规实施

20150218 ECA新闻：供应链：一系列的新法规实施  

2015-02-27 20:09:39|  分类： ECA新闻

GMP News
18/02/2015

Supply Chain: A Series of new Regulations in Force

供应链：一系列的新法规实施

The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.

新的EU指令2011/62/EU及其相关法案不断改变着药品供应链。指令引入了许多委托监管法案，有不同的实施计划日期，对EU GMP指南的各章节修订也产生了一些影响。

Here is the status quo of the Directive and the delegated acts:

这是是指令和委托监管法案的状态：

Already in 2011, the European Commission published Directive 2011/62/EC, the so called Falsified Medicines Directive(or FMD).The main goal was the fight against counterfeit medicines. In 2014 the technical characteristics of one key requirement were defined, the unique identifier delivering the possibility of verification of the authenticity of single folding boxes. This will be a 2D barcode (data matrix). As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.

2011年，欧盟委员会已公布了指令2011/62/EC，也称为药品防伪指令（或FMD）。主要目标是防止假药。在2014年，定义了一个关键要求的技术特性，唯一识别码使得核实单个盒子的真实性成为可能。唯一识别码将是二维码（数据矩阵）。由于新的要求将于2018年实施，现在是时间开始定义技术实施策略和变更控制策略了。

The new EU GDP Guidelines have been effective since 2013 (2013/C343/01). These requirements highlighted the need for an effective quality management system supported by risk assessment and appropriate controls in the distribution chain.

新的EU GDP指南自2013年开始生效（2013/C343/01）。这些要求强调了需要有效的、由风险评估和适当的销售链控制的质量管理体系。

The new GDP Guidelines apply not only to the wholesalers and manufacturers of pharmaceuticals; they also incorporate the specific requirements for the Brokers dealing with pharmaceutical products. The responsibility for the product during storage and distribution will remain with the manufacturers up to the point of sale, where wholesale dealers will take ownership of the products. It is clear that those playing a role in the pharmaceutical supply chain now have to comply with these requirements, therefore the service providers such as transportation companies and logistic service providers need to gain good understanding of what is required to be able to provide appropriate service to their clients.

新的GDP指南不仅适用于药品批发销和生产商，也结合了对从事药品行业的代理商的特殊要求。药品存贮和运输期间的责任仍属于生产商直至销售点，从销售点开始批发商获得药品的所有权。很显然，这些在药品供应链中承担一定角色的方面都必须符合这些要求，因此，所有提供服务的各方，如运输公司、物流服务公司均需要理解需要向他们的客户提供哪些适当的服务。

In 2014, the Pharmaceutical Inspection Co-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 EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely.

在2014年，药品检查合作组织PIC/S公布了PIC/S药品GDP指南（PE 011-1）。该指南是基于EU GDP指南的（2013/C 343/01），基本完全引用了EU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" of the EU GDP Guide is not quoted in the PIC/S document.

但是，EU特定的引用被删除了，术语“必须”基本都使用“应”代替了。PIC/S文件中并没有引入专门的责任人。它谈到了“委任的责任人”或“委任的人员”。在PIC/S文件中未引用EU GDP指南的第2.2节“责任人”。

GDPs for APIs are still on their way. The "Guidelines on the principles of good distribution practices for active substances for medicinal products for human use" were published for consultation by the EU early 2013. The new guidelines address distribution organisations and distributors involved in procuring, importing, exporting, holding or supplying active substances.

原料药GDP还在起草中。“人用活性药用物质GDP通则指南”在2013年早些时候由EU公布征求意见。新的指南说明了涉入采购、进口、出口、持有或供应原料药的销售组织和销售商的内容。

GMPs for APIs: Whereas for medicinal products a GMP Directive (Directive 2003/94/EG from 8 October 2003) and detailed guidelines (Part I of the EU GMP Guide) have been existing for many years, there has been no equally binding act in all the EU members states for APIs. Only the detailed guidelines as Part II of the EU GMP Guidelines are in place. This has now been caught up on. On 25 November 2014, the "Commission Delegated Regulation (EU) No 1252/2014" was published in the Official Journal of the European Union. As the subtitle shows, this regulation is to be seen as "supplementing Directive 2001/83/EC... with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use".

原料药GMP：尽管药品的GMP指令（指令2003/94/EG自2003年月8日）和详细的指南（EU GMP指南第1部分）已存在了许多年，但并没有在所有欧盟成员国内将原料药同等绑定的法案，而只有EU GMP指南的第2部分是作为了一份详细的指南。现在要跟上形势了。在2014年11月25日，欧盟官方通讯公布了“欧盟委员会委托监管条例EU No.1252/2014”。正如子题目所显示的，该条例将被作为“指令2001/83/EC在人用药品活性物质GMP指南和原则方面的补充”。

Now, the set of rules for APIs is complete: the new regulation provides the necessary legal framework of GMP principles for APIs; the long existing Part II of the EU GMP Guide delivers further concretisation of these principles.

现在，原料药管理条例系列已经完整了。新的条例提供了原料药GMP原则所必要的法定框架；已长期存在的EU GMP指南第二部分对这些原则给出了进一步细化。

EMA has published a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template":

EMA刚刚公布了关于用作起始物料的原料药的GMP符合性，及其供应核实情况的QP声明模板，称为“QP声明模板”。

The QP Declaration should be provided in support of an application for a new marketing authorisation, variation or renewal of a medicinal product(s) authorised in the Community, using EU or national procedures within the scope of the respective Directives.

应提交QP声明来支持欧盟内新的上市许可、变更或更新申报。根据相应的指令范围不同，采用不同申报程序。

With this document, the Qualified Person confirms that an API used in manufacture of a Medicinal Product submitted for approval meets EU GMP standards. It includes all sites of full or partial manufacture of the API and the confirmation has to be based upon an audit of the API manufacturer(s).

在本文件中，QP应确认用于生产所提交批准的药品的原料药符合EU GMP标准。它包括承担全部或部分原料药生产操作的所有场所，确认应基于对原料药生产商的审计。

In 2013, hardly any other topic was as extensively discussed in the pharmaceutical environment as the so called Written Confirmation (confirming the GMP compliance of an API / of the API manufacturer). Since 2 July 2013, all APIs manufactured outside the EU have to be accompanied by a Written Confirmation, issued by the Competent Authority of the exporting country. Without this confirmation there is almost no possibility to import an API into the EU. However, one alternative to a Written Confirmation is the admission to the list of "Third Countries" with comparable inspection standards. Authorities from countries on that list do not have to issue Written Confirmations. Countries currently on the list are Australia, Japan, Switzerland and the USA. Countries under assessment are Brazil, Israel, Singapore and New Zealand.

在2013年，在制药行业中没有哪个话题比所谓的书面证明（证明原料药/原料药生产商的GMP符合性）讨论的更为广泛。自2013年7月2日，所有在EU境外生产的原料药必须由出口国的药监机构出具书面证明。没有该书面证明，则几乎没有可能将原料药出口至欧盟。当然，还有一个替代的方法是被加入具有可比性检查标准的第三国清单。列于清单中的国家药监机构不需要签署书面证明。目前列入清单的国家有澳大利亚、日本 、瑞士和美国，正在评估中的国家有巴西、以色列、新加坡和新西兰。


来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015126115713856/

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