2013年EDQM年报（节选CEP部分）----Julia

巴西木

申明：本文版权归属原作者，本翻译仅供参考。年报全文请在EDQM官网下载。

2013年EDQM年报（节选）

该年报于2014年6月发布，共包括4大部分：序言、EDQM一览、核心工作、EDQM协作委员会清单。其核心内容为“核心工作”部分，本节选即是其中的第三部分“CEP证书”。

该年报由Susanne Keitel作序，概述了2013年EDQM的工作内容及在各方面所取得的成就。

CERTIFICATION OF SUITABILITY TO THE PH. EUR. MONOGRAPHS

CEP证书

Why certification is more important than ever 为什么CEP证书比以往更加重要

As the world’s economy continues to evolve – with some markets expanding and others declining, and a growing emphasis on the free circulation of goods and services, including medicinal products – manufacturing processes and production are increasingly relocated outside of Europe. This creates new challenges for national and European authorities in terms of closely monitoring and controlling the quality of substances used in the manufacture of medicines.

由于世界经济持续发展，一些市场在扩张，而另一些市场在萎缩，带来货物和服务自由流通的增长，其中也包括了药品的流通，这使得在欧洲以外的地区进行的药品生产持续增长。这些趋势给欧盟国家和欧盟当局带来了新的挑战，需要他们能对用于药用物质的质量进行严格监管和控制。

The Certification of Suitability (CEP) procedure carried out by the EDQM aims to evaluate and validate the capacity of Ph. Eur. standards to control the quality of substances used in the production of medicinal products. The procedure therefore centralises the evaluation of data for the benefit of regulatory authorities and industry and contributes to keeping the relevant Ph. Eur. monographs up to date.

EDQM实施CEP程序的目的是对于药用物质的质量是否可以使用EP标准进行控制的情况进行评估。因此，程序将数据评估工作集中由EDQM进行，有利于药监部门和企业管理，同时有助于保持EP各论更新。

The EDQM also carries out inspections of manufacturing and/or distribution sites of active substances covered by CEPs, to ensure that Good Manufacturing Practices (GMPs) are complied with and that the information supplied under the certification procedure is accurate.

EDQM还对CEP所覆盖的活性物质生产和/或销售场所进行现场检查，以保证其GMP符合性，保证其提交申报的内容的准确性。

Key facts and figures 主要数据

The number of new applications in 2013 fell by about 10 per cent compared to the previous year (338 dossiers received), while the number of requests for revision rose by some 15 per cent (1,390 requests).

2013年新CEP申报数量比上年度下降约10%，共收到338份申报；修订申请数量则比上年度上升了15%，为1390份。

307 new certificates and 1,142 revised certificates were issued in 2013. There are currently more than 3,700 valid CEPs, covering chemical purity, the risk of transmissible spongiform encephalopathy (TSE) and herbal drug preparations. Overall, 90 per cent of new dossiers and 75 per cent of requests for revision were treated within official timelines.

2013年共签发307份新CEP证书，1142份修订后的证书。目前有效CEP证书为3700份，覆盖了化学纯度、TSE和草药制品。总体来说，90%的新申报和75%的修订申报在官方承诺的时间期限内完成审核。

In 2013, there were significant developments in the area of herbal drugs and the evaluation of herbal drug preparations. Six new CEPs for these products were issued this year, bringing the total to 12, and some policies were also revised (see below).

2013年，在草药领域和草药制剂评估方面有重大发展。2013年共签发了6份该类CEP证书，使得该类CEP证书总数达到12份，同时还对一些政策进行了修订（见下）。

Number of new CEP applications received

Within the framework of the EDQM inspection programme, 34 manufacturing sites – located mostly in Asia – were inspected with the participation of inspectors from national supervisory authorities. In addition, information on GMP compliance of 31 other sites was obtained by exchanging data with inspectorates from member states and international partners. The rate of non-compliance by sites inspected by EDQM in 2013 was high (38 per cent or 13 sites), once again demonstrating the adequacy of the risk- assessment tools to select the sites to be inspected, but also showing the lack of sustainability of GMPs for some companies which are re-inspected after one or two years.

根据EDQM检查计划，对34个生产场所---主要是亚洲的---进行了现场检查。检查中邀请了来自各成员官方的检查官参与。另外，通过交换数据平台，我们还从成员国和国际合作伙伴那里获得了31个其它生产场所的GMP符合性信息。EDQM所检查的生产场所中，GMP不符合率很高（不符合率高为38%，即13个生产场所），再次证明了采用风险评估方法选择被检查场所的必要性，同时也说明许多在1-2年内被复查的公司缺乏持续的GMP符合性。

General matters and policies 一般事务和政策

The Certification Division revised important policy documents in 2013, such as:

2013年认证中心修订了一些重要的政策性文件，例如：

?         Content of the dossier for herbal drugs and herbal drug preparations;

?         草药物质和草药制剂申报文件内容

?         Guideline on requirements for revision/renewal of CEP applications and the related documents;

?         CEP申请修订/更新及相关文件要求指南

?         Guidance for electronic and paper submissions.

?         电子和纸质申报指南

Also, following a request from EU regulators, information reported on CEPs regarding manufacturing sites was extended in July 2013 to manufacturers of intermediates.

同时，根据EU立法的要求，自2013年7月起，在CEP证书上除列出原料药生产场所信息外，同时也需要列出中间体生产场所信息。

At the end of 2013, Dr Marianne Ek (from Sweden, former chair of the Commission) was elected chair of the Steering Committee of the Certification procedure for a 3-year term of office, replacing Dr Mike Morris.

2013年年度，Marianne Ek博士（来自瑞典，前委员会主席）当选为认证程序指导委员会主席，接替Mike Morris博士，任期3年。

Following a decision by the Certification Steering Committee, a 3-person Technical Advisory Board (TAB) for herbal drugs and herbal drug preparations was created in 2013 and met for the first time in November. The TAB for chemical purity assessment met 3 times in 2013.

在认证指导委员会做出决定后，2013年EDQM创建了草药物质和草药制剂由3人组成的技术建议委员会（TAB），并在11月召开首次会议。2013年化学纯度审核TAB共召开3次会议。

Communication with partners and stakeholders 与合作伙伴和涉险人的沟通

The Certification Division was involved in a number of international platforms of collaboration, such as the International Generic Drugs Regulatory Pilot (IGDRP), the international API inspection programme, PIC/S work and the ICH Q7 Q&A Implementation Working Group.

认证中心参与了许多国际合作平台的工作，例如国际仿制药监管试点（IGDRP）、国际原料药检查组织、PIC/S工作组和ICH Q7 问答实施工作组。

As part of its collaboration with the WHO and USFDA, 4 joint inspections were carried out in 2013 with the WHO and the USFDA.

作为与WHO和美国FDA合作的一部分，在2013年EDQM与WHO和美国FDA进行了4次联合检查。

The Certification procedure also features in the EDQM’s annual meetings with industry associations to promote exchange on all aspects related to the work of the EDQM. In 2013 the Certification Division participated in consultations/meetings with APIC/ CEFIC and EFPIA.

认证程序的特色还在于EDQM与企业联合会之间的年度会议，以促进与EDQM工作相关各方面的信息交换。2013年，认证中心参与了APIC/CEFIC和EFPIA的咨询和会议。

Events 事件

The Certification Division (DCEP) took part in several international events and exhibitions throughout 2013.

认证中心（DCEP）在2013年参与了几个国际事件和展览。

DCEP staff contributed to the two training sessions on the Ph. Eur. 8th Edition organised in 2013. The second day of both sessions was dedicated to the Certification procedure, sharing advice on preparing an application, revisions and the inspection programme.

DCEP人员在2013年组织的2次EP8培训会上做了培训。两次会议的第2天都是专门讲授认证程序，提供申报、修订和检查准备工作方面的建议。

On 7 November, the EDQM organised a live webinar on “How to prepare for an inspection”. The presentations focused on understanding the EDQM’s expectations, preparing and managing the inspection, gathering evidence of compliance and an overview of what the inspectors look for. It also addressed what happens after an inspection, the possible outcomes and their consequences. A majority of the participants were from Asia and the webinar concluded with a lively Q&A session.

11月7日，EDQM组织了一次在线实时培训，主题为“如何为检查做准备”。培训集中于如何了解EDQM的期望、准备和组织检查、收集符合性证据，以及检查员想要看什么。培训还说明了在检查之后EDQM会做什么、检查可能的结果及其所带来的后果。大部分参与者来自亚洲，该在线培训会结束前还有实时问答。

Once again, the Certification Division was represented at three CPhI pharmaceutical exhibitions (in Shanghai, Frankfurt and Mumbai) and organised several face-to-face meetings with CEP holders. The aim of these meetings was to inform applicants of the practical aspects of the procedure and to assist them by clarifying misunderstandings and contributing towards resolving any difficulties they may be experiencing. There was a strong response to and interest in these personalised meetings and specific documentation was distributed to visitors to promote the procedure.

2013年，认证中心再次出席了3次CPhI原料药会展上（上海、法兰克福和孟买），并组织了与CEP持有人的几次面对面会议。这些会议的目的是告知申报者关于申报程序中一些实用方面信息，协助他们澄清误解，最终解决他们可能会遇到的困难。这些个性化的会议引起了很大反响和兴趣。同时认证中心还向参观者散发了一些资料来促进CEP认证程序。

The EDQM’s Certification Division and the Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) jointly organised a symposium in Shanghai (China) in June 2013. The audience was mainly from industry and the aim was to provide up-to-date information on the requirements of the Certification procedure for applicants in China. The WHO also gave a presentation on its prequalification of active pharmaceutical ingredients (APIs) programme.

2013年6月，EDQM认证中心和中国医药保健品进出口商会（CCCMHPE）在中国上海联合组织了一次研讨会。与会者大多来自企业。会议主要目的是给中国的申报人提供最新的认证要求。该会议上WHO也介绍了其原料药预认证程序。

Official visits 官方访问

              In 2013, the EDQM’s Certification Division welcomed officials from Brazil’s Agência Nacional de Vigil?ncia Sanitária (ANVISA). The meeting discussed ways to strengthen the exchange of information regarding the evaluation of the quality of pharmaceutical substances and inspection results of manufacturing sites.

              2013年，EDQM的认证中心迎接了来自巴西药监局（ANVISA）的官员。会议讨论了加强双方关于药用物质质量评估和对生产场所检查结果进行信息交流的方式，

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