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【奥译言】美欧GMP检查互认协议再增5个欧盟成员国

2018-12-03 09:20 ?阅读数:2815 标签:

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本月初,美国食品药品监督管理局(FDA)确认比利时、丹麦、芬兰、爱沙尼亚和拉脱维亚有能力实行GMP检查,如此一来,FDA就可以利用这些国家的检查结果,从而减少不必要的重复工作。


目前,欧盟共有19个成员国已获得FDA认可,确认其具备实行相当于美国水平的GMP检查的能力和程序。不过, 欧洲药品管理局 (EMA) 指出, 在美国FDA认可所有成员国对人用药品的GMP检查之前,进口产品仍需进行批量检测,而这一完全认可目标预计最迟将于2019年7月15日完成。


欧盟委员会于2018年11月29日表示:“互认协议将于2019年7月15日在所有欧盟成员国实施的各项计划已步入正轨。”


2019年7月15日之前,将评估是否扩展该协议的运作范围,使其涵盖兽药,并会在2022年7月15日之前评估是否将其扩展至涵盖人用疫苗和血浆衍生药物。 


 背 景 


2017年3月,美国和欧盟宣布,双方达成“GMP检查互认协议(Mutual Recognition Agreement,MRA)”,这一举措具有重要的里程碑意义。2017年6月,欧盟委员会确认FDA有能力且有符合要求的检查程序来实行等同于欧盟水平的GMP检查。


自2017年11月1日起,欧盟成员国将不会重复FDA已实行过的检查。


“在欧盟上市的药品中,约有40%来自海外。此外,约85%的欧盟上市药品至少有一个生产环节是在欧盟以外的地区进行的。”EMA表示。


此后, 美国FDA陆续确认了诸多欧盟成员国监管机构的检查能力。2017年10月,欧盟又有八个成员国与美国签署了MRA互认协议,分别为奥地利、克罗地亚、法国、意大利、马耳他、西班牙、瑞典和英国。随后在2018年3月, 增加了捷克、希腊、匈牙利和罗马尼亚, 6月增加了爱尔兰和立陶宛, 9月又增加了葡萄牙。


另外,EMA也与澳大利亚、加拿大、以色列、日本、新西兰和瑞士签订了互认协议。



英文原文



US-EU Agreement on GMP Inspections Adds 5 More Member States


The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.


A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However, the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all member states' authorities for human pharmaceuticals, which is expected to be completed no later than 15 July 2019.


"Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track," the European Commission said Thursday.


An expansion of the agreement to cover veterinary medicines will be assessed by 15 July 2019 and vaccines for human use and plasma-derived medicines by 15 July 2022. 


Background


In March 2017, the landmark agreement between the US and EU to mutually recognize drug manufacturing inspections was formed. And in June 2017, the European Commission confirmed that FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.


Since 1 November 2017, EU member states can rely on inspections from FDA to replace their inspections.


“Around 40% of finished medicines marketed in the EU come from overseas and, for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union,” EMA said.


Since then, FDA has been confirming the capabilities of regulators in EU member states. The first eight were added in October 2017 and include Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK. Then in March, Czech Republic, Greece, Hungary and Romania were added, while in June, Ireland and Lithuania were added, and Portugal was added in September.


EMA also has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.




内容来自:RAPS

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