GMP News
21/09/2016
Current Status of GDP Implementation and the Role of the RP - an Overview
GDP实施现状和RP资质----概览
In 2013 the ECA Foundation established the GDP Interest Group with the goal to support all stakeholders involved in Good Distribution Practice (GDP) by providing them with information about the implementation of GDP.
在2013年，ECA组织建立了GDP兴趣组，其目的是通过提供关于GDP实施的信息来支持所有GDP干系人。
For that purpose the Interest Group joined forces with the Pharmaceutical Quality Group (PQG) to develop an interpretation of the EU Guide on Good Distribution Practices which was published in a revised version in 2013. These interpretations can be downloaded chapter by chapter in the GDP Group Website members' area.
为此目的，兴趣组与药物质量组（PQG）联合建立了EU的GDP指南诠释，并于2013年发布了修订版本。这些诠释可以在GDP组网站上会员区逐章下载。
To find out where the EU GDP Guidelines have been implemented already as a national rule and where they are still Guidelines or possibly have another status the group set up a survey amongst its members. Here is a summary of the feedback. More details can be found on the website of ECA's GDP Working Group. Please note that this summary was done based on the feedback of the participants. ECA is not responsible for the accuracy of the information provided. If you have new information about the current status in your country please let us know in order to update the table.
为了了解EU GDP指南是否已作为国家规定正式实施，还是仍然只是指南或者是其它状态，工作组在其成员中发起了一份调查。这里是所收到反馈信息的汇总摘要。更多详情可以在ECA的GDP工作组网站上找到。请注意此汇总是根据参与者的反馈所做的。ECA不为所提供信息的准确性承担责任。如果你有你国家的最新状态信息，请告知我们以便更新此表。
Country | Status of Implementation of EU GDP Guidelines | How is it implemented | What are the requirements to become a Responsible Person (RP) | Official Authority |
国家 | EU GDP指南实施状态 | 如何实施 | 成为负责人（RP）的要求是什么 | 官方机构 |
Austria | Implemented completely | integrated in the national regulations | University degree in pharmacy, medicine, chemistry, biology or similar. 2 years relevant working experience. (AMBO §7) | AGES |
奥地利 | 全面实施 | 整合到其国家法规中 | 药学、医学、化学、生物学及相关专业本科，2年相关工作经验（AMBO §7） | AGES |
Belgium | Implemented completely | Official translation has been implemented | no info | FAGG |
比利时 | 全面实施 | 已实施官方翻译版本 | 无信息 | FAGG |
Bulgaria | in process of implementation | ongoing | Bulgarian Drug Agency | |
保加利亚 | 实施中 | 进行中 | 保加利亚药物局 | |
Denmark | Implemented completely | integrated in the national regulations | Preferably a pharmacist | DMA |
丹麦 | 全面实施 | 整合至国家法规中 | 最好是药师 | DMA |
France | Implemented completely | integrated in the national regulations | As defined in EU GDP Guidelines | ANSM |
法国 | 全面实施 | 整合至国家法规中 | 按EU GDP指南中定义的要求 | ANSM |
Germany | Implemented completely | Official translation has been implemented | According to EU-GDP-Guide. A degree in pharmacy is not a must. The Responsible Person should have appropriate experience as well as knowledge of and training in GDP. | Local (federal) competent Authority |
德国 | 全面实施 | 已实施官方翻译版本 | 根据EU GDP指南。 药学专业本科不是必须。负责人应具备适当的经验和GDP知识，并接受过GDP培训。 | 当地（州）药监 |
Hungary | Implemented completely | integrated in the national regulations | Pharmaceutical degree | NIP |
匈牙利 | 全面实施 | 整合到国家法规中 | 药学专业本科 | NIP |
Ireland | Implemented completely | integrated in the national regulations | As defined in EU GDP Guidelines | HPRA |
爱尔兰 | 全面实施 | 整合到国家法规中 | 按EU GDP指南要求 | HPRA |
Lithuania | Implemented completely | Official translation has been implemented | Pharmaceutical degree | State Medicines Control Agency |
列支敦士克 | 全面实施 | 已实施官方翻译版本 | 药学专业本科 | 国家药监局 |
Malta | Implemented completely | Official translation has been implemented | Pharmaceutical degree | Medicines Authority of Malta |
马尔他 | 全面实施 | 已实施官方翻译版本 | 药学专业本科 | 马尔他药监局 |
Netherlands | Implemented completely | integrated in the national regulations | Preferably pharmacist | IGZ |
荷兰 | 全面实施 | 整合到国家法规中 | 最好是药师 | IGZ |
Norway | Implemented completely | Official translation has been implemented | no info | Norwegian Medicine Agency |
挪威 | 全面实施 | 已实施官方翻译版本 | 无信息 | 挪威药监局 |
Poland | in process of implementation | ongoing | Main Pharmaceutical Inspectorate | |
波兰 | 实施中 | 进行中 | 主要药品检查局 | |
Romania | Implemented completely | integrated in the national regulations | Pharmaceutical degree, at least 2 years of experience in GDP/GMP | National Agency for Medicines and Medical Devices |
罗马尼亚 | 全面实施 | 整合到国家法规中 | 药学专业本科，至少2年GDP/GMP经验 | 国家药监局 |
Spain | Implemented completely | Official translation has been implemented | The same as a QP(Pharmacist degree or equivalent) plus specific courses in GDP | AEMPS |
西班牙 | 全面实施 | 已实施官方翻译版本 | 与QP（药师级别或相当）要求相同，加上GDP指定课程 | AEMPS |
Switzerland | Implemented completely | integrated in the national regulations | Pharmacist, but other qualification may be accepted by Swissmedic based on education and experience | Swissmedic |
瑞士 | 全面实施 | 整合到国家法规中 | 药师，也根据教育程度和其经验可以接受其它资质 | 瑞士药监局 |
U.K. | Implemented completely | integrated in the national regulations | As defined in EU GDP Guidelines | MHRA |
英国 | 全面实施 | 整合到国家法规中 | 按EU GDP指南要求 | MHRA 来源： |
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