GDP实施现状和RP资质----概览

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： Julia

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