[新闻] 欧美澳药监机构对境外的API生产商进行联合检查

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The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and the US Food and Drug Administration (FDA):

国际药品法规当局联盟（ICMRA）发布了一份很有意思的对全球药监机构GMP检查活动的概览。它也显示出EU和US FDA之间的不同方法。

EMA/FDA/TGA API Programme 

欧洲EMA/美国FDA/澳大利亚TGA原料药检查计划

This programme of the European Medicines Agency (EMA), the European Directorate of the Quality of Medicines and Healthcare (EDQM), the European National Supervisory Authorities, the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and the World Health Organization (WHO) tries to foster the cooperation and mutual confidence between the participants through better communication and exchange of information on inspection planning. It covers joint inspections of API manufacturers located outside the participating regions but also the reliance on API inspections by other authorities.

欧盟EMA、EDQM、欧洲国家监管当局 、美国FDA、澳大利亚TGA和WHO的这个计划试图通过更好的沟通和交换检查计划信息在参与方之间建立合作和互信。它包括对参与方境外的API生产商进行联合检查，也包括依赖其它药监局的API检查。

EMA/FDA Mutual reliance Confidence building

欧洲EMA/美国FDA互相依赖信任度建立

The overall objective of this initiative is to allow some inspections on each others' territories to be deferred or waived completely based on a number of considerations.

该活动的总体目的是可以根据大量的考量推迟甚至完全豁免对彼此境内的一些检查。

EMA/FDA Finished Products programme欧洲EMA/美国FDA制剂检查计划

This programme is closely related to the one above. Here, EMA and FDA are evaluating whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication, limited to inspections of manufacturers of human medicinal (finished drug) products which come under the authority of FDA's Center for Drug Evaluation and Research and the centralised marketing authorisation process in the EU.

本计划与上面那个紧密相关。这里，EMA和FDA正在评估是否更大的国际合作有助于更好地增加检查能力，让更多场所受到监控，减少不必要的重复检查，仅限于FDA的CDER和EU 集中审评程序中的人药（制剂）生产商检查。

PIC/S Pharmaceutical Inspection Co-operation Scheme 

PIC/S 药品检查合作组织

Inspectorates from various EU Member States and the FDA are member of PIC/S which tries to foster the international co-operation in the field of GMP by developing and promoting harmonised GMP standards and guidance documents, training GMP inspectors, assessing (and reassessing) GMP inspectorates and facilitating co-operation and networking and planning of inspection.

各EU成员国检查团和FDA检查团是PIC/S的成员，该组织试图通过建立和促进统一GMP标准和指南文件、培训GMP检查员、评估（和重新评估）GMP检查团和促进合作和网络及检查计划来建立GMP领域的国际合作。

The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to

国际药品法规监管机构联盟（ICMRA）是一个自发的实施层面的战略合作组织，它倡导和领导法规监管机构一起：

• address current and emerging human medicine regulatory and safety challenges globally, strategically and in an on

  going, transparent, authoritative and institutional manner

  以持续、透明、权威和专业的方式解决全球范围内现行和新出的人药法规和安全挑战，给出策略

• provide direction for areas and activities common to many regulatory authorities' missions

  为许多药监当局的使命指出日常工作领域和活动的方向

• identify areas for potential synergies

  识别可能协作的领域

• wherever possible, leverage existing initiatives/enablers and resources

  在可能时平衡措施/发起人和资源

ICMRA wants to provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.

ICMRA想要提供一份全球架构来支持强化的沟通、信息分享、危机响应和解决法规科学问题。

The overview is available as ICMRA - Mapping of GMP Inspection Initiatives

概览可以从上述网址获得。

    

来源：Julia法规翻译