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): EMA/FDA/TGA API Programme 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. (该项目为EMA/EDQM/EU各成员国监管机构/FDA/TGA/WHO沟通各自的API检查计划，包括实施对参与国以外的API场地进行联合检查，同时该其他国家监管机构可以依靠该API场地检查结果，或者代表其他国家监管机构进行扩展API场地检查。这个以前海正就被联合检查了） EMA/FDA Mutual reliance Confidence building 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. （该项目为EMA/FDA可以互相依靠各自对其国内生产场地的检查结果。这个已经达成） EMA/FDA Finished Products programme 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. （该项目为针对于人药制剂（CDER和EMA集中审评管理下的制剂），采用EMA/FDA联合检查的形式，对两国以外的生产场地进行检查） PIC/S Pharmaceutical Inspection Co-operation Scheme 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. 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 - address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner
- provide direction for areas and activities common to many regulatory authorities' missions
- identify areas for potential synergies
- wherever possible, leverage existing initiatives/enablers and resources
ICMRA wants to provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues. The overview is available as ICMRA - Mapping of GMP Inspection Initiatives
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发表于 2017-10-20 14:05:17
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好资料，收藏了