原创 2018-02-24 julia Julia法规翻译
30 November 2017 EMA/INS/GMP/504401/2017
Inspections, Human MedicinesPharmacovigilance & Committees Division
Work plan for the GMP/GDP Inspectors Working Group for2018
GMP/GDP检查工作组2018年工作规划
Chairperson: Brendan Cuddy 主席：布莱登•卡蒂
Adopted: December 2017 采纳日期：2017年12月
The activities outlined in the work planfor 2018 have been agreed in view of preparation for the Agency’s relocation asa result of the UK’s exit from the EU and its impact on the Agency’s businesscontinuity, and may be subject to further review and reprioritisation inaccordance with the business continuity plan of the Agency.
在此2018年工作计划中所列活动已考虑到英国脱欧导致的EMA迁址准备工作，及其对EMA业务持续性的影响。计划可能会依EMA的业务持续计划进行进一步审核和优先顺序调整。
1. Meetings scheduled for 2018 2018年会议计划
Face-to-face meetings are planned for thefollowing dates: 现场会议规划如下：
• 27 February – 1 March2018 2018年2月27日至3月1日
• 4 – 6 June 20182018年6月4-6日
• 4 – 6 December2018 2018年12月4-6日
Three meetings of the Compliance Group inthe margins of the GMP/GDP IWG meetings.
三次合规组的会议在GMP/GDPIWG会议空档期。
A meeting with the group’s InterestedParties is planned to coincide with the December 2018 meeting (5 December).
计划在2018年12月会议同时举办与工作组利益相关方的会议（12月5日）。
Drafting group meetings will normally beheld by teleconference but other virtual meeting technology may be used.
起草组会议通常采用电话会议，但可能也会使用其它虚拟会议技术。
2. Guidelines 指南
2.1. NewEU Guidelines EU新指南
Action: Lead （职责：领导）
GMP Guide: Annex 21 (Importation ofmedicinal products) GMP指南：附录21（药品进口）
Target date 目标时间 | |
| To provide the European Commission with a final text for publication. 为EC提供最终文本供其发布 |
GMP and Marketing Authorisation Holders GMP和上市许可持有人
Target date 目标时间 | |
| To finalise a Reflection Paper on the relationship between GMP Compliance and the responsibilities and activities of Marketing Authorisation Holders and Manufacturing Authorisation Holders. 定稿上市许可持有人和生产许可持有人之间GMP合规与职责和活动之间关系的概念文 |
Action: Specialised input （职责：提出专家意见）
Guideline on the sterilisation of themedicinal product, active substance, excipient and primary container,EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V)
制剂、原料药、辅料和内包容器灭菌指南，EMA/CHMP/CVMP/QWP/BWP/850374/2015(H/V)
Leading group 领导组 | Quality Working Party (QWP) 专家工作组（QWP） |
| Final guideline to be published Q2 2018 2018年第2季度发布最终指南 |
| Public consultation of the draft guideline ended 13 October 2016. 2016年10月13日发布指南草案征求公众意见 |
2.2. EUGuidelines under revision EU指南修订
Action: Lead （职责：领导）
GMP Guide: Introductions GMP指南：介绍
Target date 目标时间 | |
| To provide the European Commission with a final text in view of recent changes to the legal basis for GMP affecting the overall structure of EU GMP guidance, including authorised products, IMPs, ATMPs and active substances. 向EC提供最终文稿，反映影响EU GMP指南全面结构的最新GMP立法依据变化，包括许可药品、IMP、ATMP和原料药。 |
GMP Guide: Chapter 1 (PharmaceuticalQuality System) GMP指南：第1章（药物质量体系）
Target date 目标时间 | |
| To draft a proposal to amend the chapter in order to encourage industry adoption of risk-based approaches to prevention of shortages, taking account initiatives such as HMA-EMA Taskforce and the industry inter-association guidelines. 起草一份提议修订该章，从而鼓励企业采用基于风险的方法防止药品短缺，同时考虑如HMA-EMA工作组倡议和行业内协会指南。 |
GMP Guide: Chapter 4 (Documentation) GMP指南：第4章（文件）
Target date 目标时间 | |
| To draft a proposal to amend the chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Annex 11 (Computerised Systems). To work with GCP IWG, GLP IWG and PhV IWG on this topic. 起草一份提议以修订该章，从而确保GMP环境下的数据完整性。此工作将与附录11（计算机化系统）的类似考量同步进行。 与GCP IWG、GLP IWG和PhV IWG合作此主题。 |
GMP Guide: Annex 1 (Manufacture of SterileMedicinal Products) GMP指南：附录1（无菌药品生产）
Target date 目标时间 | |
| To incorporate guidance included in Q&As dealing with the production of Water for Injections by Reverse Osmosis and control of biofilms. To provide the European Commission with a final text for publication. 整合关于注射用水反渗透法制备和生物膜控制的问答中所含指南 为EC提供最终文稿供发布 |
GMP Guide: Annex 11 (Computerised Systems)GMP指南：附录11（计算机化系统）
Target date 目标时间 | |
| To draft a proposal to amend the chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Chapter 4 (Documentation). To work with GCP IWG, GLP IWG and PhV IWG on this topic. 起草一份提议以修订该章，从而确保GMP环境下的数据完整性。此工作将与第4章（文件）的类似考量同步进行。 与GCP IWG、GLP IWG和PhV IWG合作此主题。 |
Action: Specialised input （职责：提出专家意见）
Guideline on the manufacture of thefinished dosage form (V) 制剂生产指南（V）
Leading group 领导组 | Quality Working Party (QWP) 质量工作组（QWP） |
| Draft guideline to be released for 6 month public consultation Q1 2018 2018年第1季度发布指南草案征求公众意见6个月 |
| Public consultation of the concept paper ended 17 October 2015. 2015年10月17日概念文征求公众意见截止 |
Guideline on quality of water forpharmaceutical use (H+V)
Leading group 领导组 | Quality Working Party (QWP) 质量工作组（QWP） |
| Draft guideline to be released for 6 month public consultation Q3 2018 2018年第3季度发布指南草案征求公众意见6个月 |
| Public consultation of the concept paper ended 6 June 2017. 2017年6月6日发布概念文件征求公众意见 |
2.3. ICHGuidelines ICH指南
ICH Q12 (Lifecycle Management 生命周期管理)
Target date 目标时间 | |
| Step 2b initiated in November 2017 Step 2a initiated in June 2017 Step 1 initiated in September 2014 To support the EU members of the Expert Working Group (EWG) in developing the guideline with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects. 2017年11月启动2b阶段 2017年6月启动2a阶段 2014年9月启动第1阶段 支持EU成员专家工作组（EWG）制订指南，特别强调GMP检查和药物质量体系方面 |
2.4. Otherguidance 其它指南
Action: Lead （职责：领导）
Q&As on the implementation of theupdated shared facilities guidance 更新后的共用设施指南实施问答
3. Medicinal Product-specific activities 药品特定活动
3.1. Pre-Authorisationactivities 批准前活动
• Contribution toscientific advice procedures as required.
• 按要求支持科学建议程序
3.2. Evaluationand supervision activities评估和监管活动
• Contribution to marketingauthorisation procedures as required;
• 按要求支持上市许可程序
• Agreement on EMA’s annualre-inspection programme;
• 议定EMA年度再检查计划
• Development of procedures andco-ordination of inspections relating to centrally authorised products andplasma master files for third-country blood establishments;
• 起草程序，协调与集中审评药品和第三国血液场所的血浆主文件有关的检查；
• Making best use of EUinspection resources by leveraging information from international regulatoryauthority partners wherever possible and implementing other risk-basedapproaches agreed in Union procedures. Consideration will also be given toleveraging knowledge gained from the equivalency assessments involved in thelisting of third countries by virtue of Article 111b of Directive 2001/83/ECwhen planning inspections of active substance manufacturers;
• 可能情况下，通过权衡国际药监机构伙伴的信息，最大程度利用EU检查资源；实施其它欧盟程序协定的基于风险的方法。在规划原料药生产商现场检查时，依指令2001/83/EC第111b条，同时考虑权衡第三国列表中等同性评估所获得的知识；
• GMP expertise and support toscientific aspects related to accelerated access schemes;
• GMP专业意见，支持与加速准入计划有关的科学问题
• Review of GMP provisions in thecontext of ‘disruptive innovation’ and propose revisions to GMP guidanceinterlinking with EMA Innovation Task Force and similar initiatives, asappropriate.
• 依“颠覆性创新”要求审核GMP条款，为与EMA创新任务和类似倡议（适用时）相关的GMP指南提出修订建议
4. Input into European activities 欧洲活动
4.1. Collaborationwith European Commission 与EC的协作
• EU enlargement: to developcontacts and collaboration in the field of GMP and GDP inspections with EUcandidate and accession countries identified by the European Commission. Thesecountries are invited to observe meetings of GMP/GDP IWG.
• EU扩大：EU参与人和EC识别的加入欧盟的国家一起发展GMP和GDP检查领域的联络与协作。邀请这些国家观察GMP/GDP IWG会议。
• Legislative developments: tomonitor new legislation, to assess and advise on potential impact on GMP, GDP,inspections or inspection-related activities. Particular attention will begiven to:
• 立法开展：监测新法，评估其对GMP、GDP、检查或检查相关活动的潜在影响并提出建议，特别注意：
- Assessment of the impact of theClinical Trials Regulation (Regulation (EU) No 536/2014) on GMP inspection andrelated activities and agree on practical implementation steps;
- 评估临床试验法规（法规EU536/2014）对GMP检查和相关活动的影响，商议实际实施步骤；
- Development of new legislationfor veterinary medicinal products.
- 起草兽药新法。
• Article 111b(1) equivalencyassessment: to support the European Commission in the equivalency assessment ofthe supervision of active substance manufacturers by third country authoritiesat their request.
• 第111b（1）条等同性评估：在第三国药监机构提出请求时，支持EC对原料药生产商监管的等同性评估
4.2. JointAudit Programme 联合审计计划
• To ensure auditor resourcecontribution to the audit programme;
• 确保审计员资源，支持审计计划；
• To collaborate with PIC/S(Pharmaceutical Inspection Convention/Co-operation Scheme) and MRA (MutualRecognition Agreement) partners in joint audits.
• 与PIC/S和MRA伙伴协作联合审计。
Through the Compliance Group: 通过合规组：
• To ensure that the agreed auditprogramme for 2018 is carried out and to report to the Heads of MedicinesAgencies on the 2017 programme;
• 确保协定的2018年审计计划实施，向HMA报告2017年计划；
• To implement risk-based auditprocedures;
• 实施基于风险的审计程序；
• To monitor the results ofaudits and follow up as necessary;
• 监测审计结果并按需追踪；
• To develop a formal process forthe follow-up of significant issues raised in the programme.
• 起草一份正式的计划中发生的重大问题跟踪流程。
4.3. Compilationof Union Procedures on Inspections and Exchange of Information 欧盟检查和信息交换程序汇编
• To finalise the update of theprocedure for dealing with serious GMP non-compliance;
• 定稿更新后的严重GMP不符合处理程序；
• To finalise the procedure fordealing with serious GDP non-compliance;
• 定稿严重GDP不符合处理程序；
• To update the ManufacturingAuthorisation and GMP certificate interpretation documents (i.e. “SpecialRequirements” menu) as part of the implementation of the revised GMP guidanceon shared manufacturing facilities;
• 更新生产许可和GMP证书解释文件（即“特殊要求”清单）作为修订后共用生产设施GMP指南实施的一部分；
• To revise the procedures forhandling Quality Defects and Rapid Alerts;
• 修订质量缺陷和快速警报处理程序；
• To harmonise practices inrelation to GMP certificates and non-compliance statements;
• 协调GMP证书和不符合声明有关的规范；
• To continue to identify GMP andGDP inspection related topics for development as Union procedures;
• 持续识别GMP和GDP检查相关主题，制订为欧盟程序；
• To identify and implement, asneeded, editorial updates following the entry into force of the new delegatedregulation for GMP, the Clinical Trial Regulation and GMP for IMP;
• 识别并实施（需要时）新的GMP托管法案、临床试验法规和IMP的GMP实施后的编辑性更新；
• To identify and implement, asneeded, updates following the publication of the GMP guideline for ATMPs.
• 识别并实施（需要时）ATMP的GMP指南发布后的更新。
4.4. EudraGMDPdatabase 欧盟GMDP数据库
• To continue to overseethe EudraGMDP database;
• 持续监管欧盟GMDP数据库；
• To support theintegration of the database with the Agency’s Master Data Management project;
• 支持该数据库与EMA主数据管理项目的整合；
• To promote further useof the planning module as a tool for EU and international collaboration;
• 促进更多利用规划模型作为EU和国际协作工具；
• To identify andimplement, as needed, editorial updates following the entry into force of thenew delegated regulation for GMP, the Clinical Trial Regulation and GMP forIMP.
• 识别并实施（需要时）新的GMP托管法案、临床试验法规和IMP的GMP实施后的编辑性更新。
4.5. Trainingfor the network and knowledge management 网络和知识管理培训
• Support one annualinspector training event during 2018.
• 支持2018年的一次年度检查员培训
• Develop a plan in orderto deliver training in response to the “Multiannual work programme to 2020”.
• 起草一份计划以进行为响应“2020年目标互认工作计划”所做的培训。
4.6. OtherEU collaborations 其它EU协作
To maintain dialogue and monitordevelopments in areas of common interest in order to communicate the work ofthe group and to assess the impact of other groups’ activities on GMP and GDPguidance, Compilation of Union Procedures and other inspection relatedactivities:
在共同利益领域内保持对话、监测发展，以沟通组内工作，并评估其它组活动对GMP和GDP指南、欧盟程序汇编和其它检查相关活动的影响：
• Joint CHMP/CVMP QualityWorking Party;
• 联合CHMP/CVMP质量工作组；
• EU Process AnalyticalTechnology team;
• EU过程分析技术组；
• Biologics Working Party;
• 生物制品工作组；
• Safety Working Party;
• 安全工作组；
• Heads of MedicinesAgencies’ Working Group of Enforcement Officers.
• HMA工作组执行官员。
4.7. Otherinput into European activities 其它欧洲活动
The group will undertake any other relevantwork referred to it by the European Commission, Heads of Medicines Agencies orthe scientific committees of the European Medicines Agency. This will includecontributing as needed in the EU regulatory network’s response to crisesresulting from serious quality/manufacturing problems and/or GMPnon-compliance.
本组将承担其它EC、HMA和EMA科学委员会指派的相关工作。其中包括按需求支持EU法规网络对严重质量/生产问题和/或GMP不符合性问题导致的危机响应。
5. Input into International activities(beyond ICH guidelines) 国际活动（ICH指南除外）
To continue to promote and strengtheninternational collaboration and convergence through the existing MRA platformsand other programmes (ICMRA – International Coalition of Medicines RegulatoryAuthorities, PIC/S, WHO) with a view to supporting capacity building.
通过现有的MRA平台和其它项目（ICMRA—国际药品法规机构协作，PIC/S，WHO），持续促进和加强国际协作，致力于支持能力建设
5.1. MutualRecognition Agreements 互认协议
To support the European Commission in theequivalency assessment of the supervision of finished product manufacturers bythird country authorities at their request for any new agreements or changes toexisting agreements.
在第三国药监机构请求下，支持EC为所有新协议或现有协议修订对制剂生产商监管等同性评估。
To promote alignment of MRA maintenanceprogrammes between the different MRA partners.
促进不同MRA伙伴之间MRA维护计划一致性。
To continue progress towards the use of theEudraGMDP database by MRA partners to replace the paper exchange of GMPcertificates.
持续推进MRA伙伴对欧盟GMPD数据库的使用，以取代GMP证书的纸质互换。
• Australia 澳大利亚
To continue to maintain the functioning ofthe MRA;
持续维护MRA的作用；
To support the European Commission inassessment efforts should APVMA request recognition as equivalent inspectorate.
支持EC评估APVMA请求认可作为等同性检查组。
• Canada 加拿大
To support the implementation and ongoingmaintenance of the Comprehensive Economic and Trade Agreement (CETA).
支持实施和持续维护全面经贸协议（CETA）
• Israel 以色列
To continue to improve and maintain thefunctioning of the MRA (ACAA - Agreement on Conformity Assessment andAcceptance).
持续改进和维护MRA的作用（ACAA—符合性评估和可接受度协议）
• Japan 日本
To continue to maintain the functioning ofthe MRA.
持续维护MRA的作用
• New Zealand 新西兰
To continue to maintain the functioning ofthe MRA.
持续维护MRA的作用
• Switzerland 瑞士
To continue to maintain the functioning ofthe MRA.
持续维护MRA的作用
• United States of America美国
To continue to support the implementationof the EU-US MRA.
持续支持实施欧美MRA
5.2. Othercollaborations 其它协作
• EDQM (EuropeanDirectorate for the Quality of Medicines and Healthcare)
To continue collaborative activities aimedat optimising the use of inspection resources and capacity building.
持续协作活动，优化检查资源使用和检查能力建设
• India and China印度和中国
To support collaborative initiatives withIndian and Chinese regulators (e.g. capacity building and training on EU GMPstandards).
支持与印度和中国法规机构的合作性倡议（例如，能力建设和EU GMP标准培训）
• International collaboration onsupervision of Heparin supply chain 肝素供应链监管国际协作
To develop and implement an appropriatesupervision plan for the heparin supply chain in consultation withinternational partners.
与国际伙伴讨论，制订和实施适当的肝素供应链监管计划
6. Contribution to dialogue and engagementwith stakeholders and external parties 支持与干系人和外部组织的对话和参与
6.1. Workshops研讨会
To support training for inspectors on theimplementation of the updated shared facilities guidance.
支持检查员关于更新后共用设施指南实施的培训
6.2. Otheractivities with stakeholders and external parties 与干系人和外方的其它活动
Improve collaboration with Industryassociations and relevant professional associations (Interested Parties).
提升与行业协会和相关专业协会（利益相关方）的协作
In addition to the actions identifiedabove, the Working Group can be involved in any other activities foreseen inits mandate:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004873.pdf
除了上述所列措施，工作组还会参与任何其职责范围内可预见的其它活动
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发表于 2018-3-1 06:50:27
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