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欧盟FDA拟2017年互认

来源:医药魔方   日期:2016-11-18   
EMA和美国FDA之间关于制药场所现场检查的互认协议可能将于2017年1月签署。“会议中讨论了美国和EU GMP检查团的评估组织和发展情况。根据目前进展,考虑将于2017年1月签署GMP检查的互认协议。”

EMA/ FDA Mutual Recognition Agreement moving forward

EMA/FDA互认协议向前推进

A possible agreement between the European Medicines Agency EMA and the US Food and Drug Administration FDA on mutual recognition of drug facility inspections could already be signed in January 2017. This is noted in a report of the EU Commission: "The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections by January 2017 is under consideration."

EMA和美国FDA之间关于制药场所现场检查的互认协议可能将于20171月签署。会议中讨论了美国和EU GMP检查团的评估组织和发展情况。根据目前进展,考虑将于20171月签署GMP检查的互认协议。

But, according to the Commission, some issues are still not resolved - like, for example, the exchange of confidential information and the inclusion of veterinary products in the scope of the text.

但是,根据欧盟委员会的说法,仍有一些问题有待解决----比如,保密信息的交换,兽药是否包括在协议范围内.

The "Report of the 15th Round of Negotations for the Transatlantic Trade and Invesment Partnership" summaries the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP) from 3rd to 7th October 2016 in New York.

跨大西洋贸易和投资伙伴关系第15轮磋商报告中总结了2016103-7日在纽约召开的跨大西洋贸易和投资伙伴关系(TTIP)第15轮谈判的内容。

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