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自2017-11-01日开始，欧盟和FDA相互承认对方的GMP现场检查结果。FDA已经完成对8个欧盟国家（奥地利，克罗地亚，法国，意大利，马耳他，西班牙，瑞典和英国）医药管理当局和GMP现场检查的能力的评估，认为达到了FDA水平。对欧盟其它成员国的评估要在2019年完成。欧盟医药当局也确认FDA监管能力与欧盟相当。相互承认后可以大大提高对医药制造上的GMP监管，降低管理成本。
EU-US FDA mutual recognition of inspections of medicines manufacturers enters operational phase 1st November 2017 marks the beginning of mutual recognition of inspections of manufacturing sites for human medicines between the US and eight Member States of the European Union (Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom). The US Food and Drug Administration (FDA) has completed the capability assessments of drug manufacturing regulatory authorities in these eight EU Member States, recognising them as capable to carry out good manufacturing practice (GMP) inspections. The remaining Member States will be assessed by the FDA on a rolling basis, to be completed by 15 July 2019. For its part, the European Commission confirmed that the US FDA has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU, earlier in the year. This important agreement, which updates the mutual recognition agreement from 1998, strengthens reliance upon each other’s inspection expertise and resources. Mutual benefits for EU authorities and the FDA include: The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured; Prioritising inspections of medicines manufacturing sites for higher risk cases; Reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured; Improving the ability to identify and address problems at manufacturing sites before they become a public health risk; and Reducing the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers. To make this agreement operational, teams from the EU national competent authorities, European Commission, European Medicines Agency and the US FDA have been working intensively on auditing and assessing the respective supervisory system. Mutual recognition covers medicinal products for human use with the exception of vaccines, plasma derived medicinal products and investigational medicinal products (clinical trial material).
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发表于 2018-1-28 16:28:46
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