{"id":101064,"date":"2019-05-05T00:00:50","date_gmt":"2019-05-17T08:34:08","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/101064\/"},"modified":"2019-05-17T16:34:09","modified_gmt":"2019-05-17T08:34:09","slug":"632488fe4b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/101064\/","title":{"rendered":"EMA\uff1a\u6b27\u7f8e\u4e92\u8ba4\u589e\u52a0\u4fdd\u52a0\u5229\u4e9a\u548c\u585e\u6d66\u8def\u65af"},"content":{"rendered":"
\n

\u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1<\/span><\/p>\n

30 April 2019<\/span>
<\/p>\n

EMA\/238100\/2019<\/span><\/p>\n

Committeesand Inspections<\/span><\/p>\n

Questions & answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 30 April 2019<\/strong><\/span><\/p>\n

2019*<\/strong>*\u5e744\u670830\u65e5\u8d77\u6b27\u7f8e\u95f4\u4e92\u8ba4\u534f\u8bae\u5f71\u54cd\u95ee\u7b54**<\/span><\/p>\n

Q1:What is in place since 1 November 2017?<\/span><\/p>\n

A1:The provisions of the agreement relating to the mutual recognition of inspections took effect on 1 November 2017. This milestone followed the confirmation, in June 2017, by the European Commission (EU) that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU and on 1 November, the confirmation by the FDA of the capability of eight Member States \u2013Austria, Croatia, France, Italy, Malta,Spain, Sweden and United Kingdom.<\/span><\/p>\n

FDA confirmed the capability of the following further Member States on:<\/span><\/p>\n

–      1 March 2018: Czech Republic, Greece, Hungary and Romania<\/span><\/p>\n

–      1 June 2018: Ireland and Lithuania<\/span><\/p>\n

–      14 September 2018: Portugal<\/span><\/p>\n

–      16 November 2018: Belgium, Denmark, Finland and Latvia<\/span><\/p>\n

–      28 November 2018: Estonia;<\/span><\/p>\n

–      7 February 2019: Poland and Slovenia;<\/span><\/p>\n

–      29 April 2019: Bulgaria and Cyprus<\/span><\/p>\n

\u95ee\uff1a\u81ea11\u67081\u65e5\u8d77\u6709\u54ea\u4e9b\u5df2\u5b8c\u6210\uff1f<\/span><\/p>\n

\u7b54\uff1a\u4e92\u8ba4\u534f\u8bae\u4e2d\u4e0e\u68c0\u67e5\u4e92\u8ba4\u6709\u5173\u7684\u6761\u6b3e\u81ea2017\u5e7411\u67081\u65e5\u5f00\u59cb\u5b9e\u65bd\u3002\u6b64\u91cc\u7a0b\u7891\u662f\u57282017\u5e746\u6708\u7531EU\u786e\u8ba4\u7f8e\u56fdFDA\u6709\u80fd\u529b\u3001\u6709\u4eba\u529b\u548c\u7a0b\u5e8f\u4ee5\u7b49\u540c\u4e8eEU\u7684\u6c34\u5e73\u6267\u884cGMP\u68c0\u67e5\u4e4b\u540e\u786e\u5b9a\u7684\u30022017\u5e7411\u67081\u65e5\uff0cFDA\u5df2\u786e\u8ba4\u4e868\u4e2a\u6210\u5458\u56fd\u7684\u68c0\u67e5\u80fd\u529b\uff08\u5965\u5730\u5229\u3001\u514b\u7f57\u5730\u4e9a\u3001\u6cd5\u56fd\u3001\u610f\u5927\u5229\u3001\u9a6c\u5c14\u4ed6\u3001\u897f\u73ed\u7259\u3001\u745e\u5178\u548c\u82f1\u56fd\uff09\u3002<\/span><\/p>\n

FDA\u786e\u8ba4\u4e86\u66f4\u591a\u6210\u5458\u56fd\uff1a<\/span><\/p>\n

–      20180301\uff1a\u6377\u514b\u3001\u5e0c\u814a\u3001\u5308\u7259\u5229\u548c\u7f57\u9a6c\u5c3c\u4e9a<\/span><\/p>\n

–      20180601\uff1a\u7231\u5c14\u5170\u548c\u7acb\u9676\u5b9b<\/span><\/p>\n

–      20180914\uff1a\u8461\u8404\u7259<\/span><\/p>\n

–      20181116\uff1a\u6bd4\u5229\u65f6\u3001\u4e39\u9ea6\u3001\u8377\u5170\u548c\u62c9\u8131\u7ef4\u4e9a<\/span><\/p>\n

–      20181128\uff1a\u7231\u6c99\u5c3c\u4e9a<\/span><\/p>\n

–      20190207\uff1a\u6ce2\u5170\u548c\u65af\u6d1b\u6587\u5c3c\u4e9a<\/span><\/p>\n

–      20190429\uff1a\u4fdd\u52a0\u5229\u4e9a\u548c\u585e\u6d66\u8def\u65af<\/span><\/p>\n

Q2:Does this Mutual Recognition Agreement mean that from 1 November 2017 EU and US regulators will stop conducting GMP inspections in each other\u2019s territories?<\/span><\/p>\n

A2: As of 1 November 2017, the EU Member States will not duplicate inspections conducted by the FDA. At the same time, it is expected that the FDA will not duplicate inspections conducted by a recognised authority*<\/span><\/p>\n

Exceptionally, both the EU and FDA reserve the right to inspect in each other’s territory at any time.<\/span><\/p>\n

\u95ee\uff1a\u6b64\u4e92\u8ba4\u534f\u8bae\u662f\u5426\u610f\u5473\u7740\u81ea2017\u5e7411\u67081\u65e5\u8d77\uff0cEU\u548c\u7f8e\u56fd\u7684\u836f\u76d1\u4eba\u5458\u4f1a\u505c\u6b62\u5bf9\u53e6\u4e00\u65b9\u9886\u571f\u5b9e\u65bdGMP\u68c0\u67e5\uff1f<\/span><\/p>\n

\u7b54\uff1a\u81ea2017\u5e7411\u67081\u65e5\u8d77\uff0cEU\u6210\u5458\u56fd\u5c06\u4e0d\u4f1a\u91cd\u590dFDA\u5df2\u6267\u884c\u8fc7\u7684\u68c0\u67e5\u3002\u540c\u65f6\uff0c\u9884\u671fFDA\u4e5f\u4e0d\u4f1a\u91cd\u590d\u7ecf\u8ba4\u53ef\u7684\u836f\u76d1\u5f53\u5c40\u5df2\u6267\u884c\u8fc7\u7684\u68c0\u67e5\u3002<\/span><\/p>\n

\u5728\u4f8b\u5916\u60c5\u51b5\u4e0b\uff0cEU\u548cFDA\u90fd\u4fdd\u7559\u6743\u529b\u5728\u4efb\u4f55\u65f6\u95f4\u5bf9\u53e6\u4e00\u65b9\u9886\u571f\u6267\u884c\u68c0\u67e5\u3002<\/span><\/p>\n

Q3:Does this Mutual Recognition Agreement mean that from 1 November 2017, EU andUS regulators can rely on each other\u2019s GMP inspections, not only in their territories but also outside the EU and the US?<\/span><\/p>\n

A3:Initially, the EU and the FDA will focus on inspections conducted within their respective territories. However, the EU and the FDA have the option to rely oninspection reports issued by a recognized authority for manufacturing facilities located outside their respective territories. See Article 3 (1) ofthe GMP Sectoral Annex to the MRA. Please note that this provision in the MRA to accept the outcome of inspections conducted outside the US or the EU, is not yet operational and further guidance will be published in due course.<\/span><\/p>\n

\u95ee\uff1a\u6b64\u4e92\u8ba4\u534f\u8bae\u610f\u5473\u7740\u81ea2017\u5e7411\u67081\u65e5\u8d77\uff0cEU\u548c\u7f8e\u56fd\u836f\u76d1\u4eba\u5458\u53ef\u4ee5\u4f9d\u8d56\u4e8e\u5bf9\u65b9\u7684GMP\u68c0\u67e5\uff0c\u9664\u4e86\u672c\u571f\u7684\u68c0\u67e5\uff0c\u662f\u5426\u8fd8\u5305\u62ecEU\u548c\u7f8e\u56fd\u4ee5\u5916\u7684\u5730\u533a\uff1f<\/span><\/p>\n

\u7b54\uff1a\u521a\u5f00\u59cb\uff0cEU\u548cFDA\u5c06\u5173\u6ce8\u4e8e\u5728\u5176\u5bf9\u5e94\u7684\u9886\u571f\u5185\u6240\u5b9e\u884c\u7684\u68c0\u67e5\u3002\u4f46\u662f\uff0cEU\u548cFDA\u4e5f\u53ef\u4ee5\u4f9d\u8d56\u4e8e\u7ecf\u8fc7\u8ba4\u53ef\u7684\u836f\u76d1\u5f53\u5c40\u5bf9\u4f4d\u4e8e\u5176\u5bf9\u5e94\u9886\u571f\u4ee5\u5916\u7684\u751f\u4ea7\u573a\u6240\u7b7e\u53d1\u7684\u68c0\u67e5\u62a5\u544a\u3002\u53c2\u89c1MRA\u7684GMP\u90e8\u5206\u9644\u5f55\u7b2c3\uff081\uff09\u6761\u3002\u8bf7\u6ce8\u610fMRA\u4e2d\u63a5\u53d7\u5728\u7f8e\u56fd\u6216EU\u4ee5\u5916\u6267\u884c\u7684\u68c0\u67e5\u7ed3\u679c\u7684\u6761\u6b3e\u5c1a\u672a\u5f00\u59cb\u6267\u884c\uff0c\u5728\u9002\u5f53\u65f6\u5019\u4f1a\u53d1\u5e03\u8fdb\u4e00\u6b65\u6307\u5357\u3002<\/span><\/p>\n

Q4:What is the difference between this agreement and the Mutual Recognition Agreement signed in 1998?<\/span><\/p>\n

A4:The EU and the US signed the agreement on mutual recognition between the European Community and the United States of America in 1998. The agreement included a Pharmaceutical Annex providing reliance on each other\u2019s GMP inspections. However, this was never fully implemented. The 2017 amendment tothe Sectoral Annex is building on the 1998 MRA. It benefits from the cooperation of the EU and the US in the past years through various pilot initiatives on GMP inspections.<\/span><\/p>\n

\u95ee\uff1a\u6b64\u534f\u8bae\u4e0e1998\u5e74\u4e92\u8ba4\u534f\u8bae\u6709\u4f55\u533a\u522b\uff1f<\/span><\/p>\n

\u7b54\uff1aEU\u548c\u7f8e\u56fd\u4e8e1998\u5e74\u7531\u6b27\u6d32\u5171\u540c\u4f53\u4e0e\u7f8e\u56fd\u7b7e\u7f72\u4e86\u4e92\u8ba4\u534f\u8bae\u3002\u534f\u8bae\u5305\u62ec\u4e00\u4efd\u836f\u4e1a\u9644\u5f55\uff0c\u4e3a\u53cc\u65b9GMP\u68c0\u67e5\u63d0\u4f9b\u4e86\u53ef\u4fe1\u6027\u3002\u4f46\u662f\uff0c\u8be5\u534f\u8bae\u4ece\u6765\u90fd\u6ca1\u6709\u5168\u9762\u5b9e\u65bd\u8fc7\u30022017\u5e74\u5bf9\u90e8\u95e8\u9644\u5f55\u7684\u4fee\u6b63\u662f\u57fa\u4e8e1998\u5e74MRA\u7684\u3002\u5b83\u5229\u76ca\u4e8eEU\u548c\u7f8e\u56fd\u5728\u8fc7\u53bb\u6570\u5e74\u4e2d\u5728GMP\u68c0\u67e5\u65b9\u9762\u5404\u79cd\u5408\u4f5c\u5c1d\u8bd5\u3002<\/span><\/p>\n

Q5:What products are included in the scope of the Mutual Recognition Agreement?<\/span><\/p>\n

A5:The indicative scope of the amended Sectoral Annex covers a broad range of human medicines, as well as biological and veterinary medicines with specific exclusions for human blood, plasma, tissues and organs as well as forveterinary immunologicals. The current operational scope of the agreement includes only human medicinal products, with the exclusion of vaccines and plasma derived products.<\/span><\/p>\n

\u95ee\uff1a\u54ea\u4e9b\u4ea7\u54c1\u662f\u5305\u62ec\u5728\u4e92\u8ba4\u534f\u8bae\u8303\u56f4\u5185\u7684\uff1f<\/span><\/p>\n

\u7b54\uff1a\u4fee\u8ba2\u540e\u7684\u90e8\u5206\u9644\u5f55\u8986\u76d6\u4e86\u4eba\u836f\u4e2d\u5f88\u5bbd\u7684\u8303\u56f4\uff0c\u8fd8\u5305\u62ec\u6709\u751f\u7269\u836f\u54c1\u548c\u517d\u836f\uff0c\u4f46\u4eba\u8840\u3001\u8840\u6d46\u7ec4\u7ec7\u548c\u7ec4\u7ec7\u4ee5\u53ca\u517d\u836f\u514d\u75ab\u836f\u54c1\u9664\u5916\u3002\u534f\u8bae\u76ee\u524d\u7684\u6267\u884c\u8303\u56f4\u4ec5\u5305\u62ec\u4eba\u836f\uff0c\u75ab\u82d7\u548c\u8840\u6d46\u5236\u54c1\u9664\u5916\u3002<\/span><\/p>\n

Q6:What products are currently excluded from the scope of the Mutual Recognition Agreement?<\/span><\/p>\n

A6: Veterinary products are not immediately included in the operational scope of the agreement, but they will be considered for inclusion by no later than 15 July 2019. To this end discussions between technical experts have been initiated. Human vaccines and plasma derived products are not immediately included within the operational scope of the agreement, but their inclusion will be considered by no later than 15 July 2022.<\/span><\/p>\n

Human blood, plasma, tissues and organs as well as veterinary immunologicals are excluded from the scope.<\/span><\/p>\n

\u95ee\uff1a\u76ee\u524d\u54ea\u4e9b\u4ea7\u54c1\u662f\u6392\u9664\u5728\u4e92\u8ba4\u534f\u8bae\u8303\u56f4\u4ee5\u5916\u7684\uff1f<\/span><\/p>\n

\u7b54\uff1a\u517d\u836f\u4ea7\u54c1\u4e0d\u4f1a\u7acb\u5373\u5305\u62ec\u5728\u534f\u8bae\u7684\u8fd0\u4f5c\u8303\u56f4\u5185\uff0c\u4f46\u6700\u8fdf\u5c06\u4e8e2019\u5e747\u670815\u65e5\u4f1a\u8003\u8651\u5c06\u5176\u5305\u62ec\u5728\u5176\u4e2d\u3002\u4eba\u7528\u75ab\u82d7\u548c\u8840\u6d46\u884d\u751f\u7269\u4e0d\u4f1a\u7acb\u5373\u5305\u62ec\u5728\u534f\u8bae\u7684\u8fd0\u4f5c\u8303\u56f4\u5185\uff0c\u4f46\u6700\u8fdf\u5c06\u4e8e2022\u5e747\u670815\u65e5\u4f1a\u8003\u8651\u5c06\u5176\u5305\u62ec\u5728\u5176\u4e2d\u3002<\/span><\/p>\n

\u4eba\u8840\u3001\u8840\u6d46\u3001\u7ec4\u7ec7\u548c\u5668\u5b98\u4ee5\u53ca\u517d\u836f\u514d\u75ab\u836f\u54c1\u4e0d\u5728\u8303\u56f4\u5185\u3002<\/span><\/p>\n

Q7:Are combination products included in the scope provided they are regulated by FDA\u2019s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in the US and registered as a \u201cmedicinal product\u201d in the EU?<\/span><\/p>\n

A7: The applicable product scope is defined by the provisions of Article 4 and Appendix 3 of the Sectoral Annex. Products falling within this scope arecovered by the MRA.<\/span><\/p>\n

\u95ee\uff1a\u7ec4\u5408\u4ea7\u54c1\u5982\u679c\u5728\u7f8e\u56fd\u662f\u53d7\u5230FDA\u7684CDER\u548cCBER\u7684\u7ba1\u5236\uff0c\u5e76\u5728\u6b27\u76df\u6ce8\u518c\u4e3a\u201c\u533b\u7597\u4ea7\u54c1\u201d\uff0c\u662f\u5426\u5305\u62ec\u5728\u8303\u56f4\u5185\uff1f<\/span><\/p>\n

\u7b54\uff1a\u9002\u7528\u4ea7\u54c1\u8303\u56f4\u662f\u7531\u7b2c4\u6761\u548c\u90e8\u95e8\u9644\u5f553\u5185\u7684\u6761\u6b3e\u5b9a\u4e49\u7684\u3002\u5c5e\u4e8e\u6b64\u8303\u56f4\u7684\u4ea7\u54c1\u5219\u5305\u62ec\u5728MRA\u91cc\u3002<\/span><\/p>\n

Q8:What will happen next?<\/span><\/p>\n

A8:The number of recognized authorities will be gradually expanded with further assessment. The next milestones are 1 June 2018 for FDA to confirm capability of a further two Member States and 1 December 2018 for six more Member States.The MRA foresees that all EU Member States are assessed by latest 15 July 2019.<\/span><\/p>\n

\u95ee\uff1a\u63a5\u4e0b\u6765\u4f1a\u53d1\u751f\u4ec0\u4e48\u4e8b\u60c5\uff1f<\/span><\/p>\n

\u7b54\uff1a\u4f1a\u6709\u8fdb\u4e00\u6b65\u8bc4\u4f30\uff0c\u88ab\u8ba4\u53ef\u7684\u836f\u76d1\u5f53\u5c40\u6570\u91cf\u5c06\u4f1a\u9010\u6b65\u589e\u52a0\u3002MRA\u9884\u8ba1\u52302019\u5e747\u670815\u65e5\uff0c\u6240\u6709\u7684EU\u6210\u5458\u56fd\u90fd\u5c06\u5b8c\u6210\u8bc4\u4f30\u3002<\/span><\/p>\n

Q9:Where can I find an up-to-date list of recognized authorities?<\/span><\/p>\n

A9:The EU is publishing the list of recognized authorities . This list will be regularly updated once a Member State has been found capable by the FDA.<\/span><\/p>\n

\u95ee\uff1a\u6211\u8981\u600e\u4e48\u627e\u5230\u66f4\u65b0\u540e\u7684\u88ab\u8ba4\u53ef\u7684\u5f53\u5c40\u6e05\u5355\uff1f<\/span><\/p>\n

\u7b54\uff1aEU\u4f1a\u53d1\u5e03\u88ab\u8ba4\u53ef\u7684\u836f\u76d1\u5f53\u5c40\u6e05\u5355\u3002\u6b64\u6e05\u5355\u5c06\u5728FDA\u8ba4\u53ef\u4e00\u4e2a\u6210\u5458\u56fd\u6709\u80fd\u529b\u4e4b\u540e\u5b9a\u671f\u66f4\u65b0\u3002<\/span><\/p>\n

Q10:Can I stop import testing now?<\/span><\/p>\n

A10:No, this provision will only enter into force once all EU Member States have been assessed and recognised by the FDA, i.e. by July 2019.<\/span><\/p>\n

\u95ee\uff1a\u6211\u73b0\u5728\u80fd\u505c\u6b62\u8fdb\u53e3\u68c0\u6d4b\u5417\uff1f<\/span><\/p>\n

\u7b54\uff1a\u4e0d\u80fd\uff0c\u6b64\u6761\u6b3e\u53ea\u6709\u5f53\u6240\u6709EU\u6210\u5458\u56fd\u5747\u7ecf\u8fc7FDA\u8bc4\u4f30\uff0c\u5373\u81f32019\u5e747\u6708\u624d\u5f00\u59cb\u6267\u884c\u3002<\/span><\/p>\n

\u5b98\u7f51\u82f1\u6587\u4e0b\u8f7d\u5730\u5740\uff1a<\/span>https:\/\/www.ema.europa.eu\/en\/documents\/other\/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-30-april_en.pdf<\/span><\/span><\/p>\n

\"EMA\uff1a\u6b27\u7f8e\u4e92\u8ba4\u589e\u52a0\u4fdd\u52a0\u5229\u4e9a\u548c\u585e\u6d66\u8def\u65af\"<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u7ffb\u8bd1\uff1aJULIA \u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1 30 April 2019 EMA\/238100\/2019 Com […]<\/p>\n","protected":false},"author":1,"featured_media":101065,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/101064"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=101064"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/101064\/revisions"}],"predecessor-version":[{"id":101067,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/101064\/revisions\/101067"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/101065"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=101064"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=101064"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=101064"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}