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	<title>GMP &#8211; Accestra Consulting</title>
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		<title>Sharing: China NMPA’s working procedure for overseas Drug Inspections</title>
		<link>https://www.accestra.com/sharing-china-nmpas-working-procedure-for-overseas-drug-inspections/</link>
		
		<dc:creator><![CDATA[mona.zhang]]></dc:creator>
		<pubDate>Mon, 24 Jun 2019 11:22:54 +0000</pubDate>
				<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[GMP]]></category>
		<category><![CDATA[Overseas drug company inspection]]></category>
		<category><![CDATA[product recall]]></category>
		<category><![CDATA[sales suspension]]></category>
		<guid isPermaLink="false">http://www.accestra.com/?p=2416</guid>

					<description><![CDATA[On December 26, 2018, China NMPA (National Medical Products Administration) released the Regulations for Drug and Device Overseas Inspection. Drugs and devices that have been approved or are applying for market in China are subject to this Regulation. The working procedure are summarized in the diagram below. And in the first half of 2019, there&#8230;]]></description>
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<p>On December 26, 2018, China NMPA (National Medical Products Administration) released the Regulations for Drug and Device Overseas Inspection. Drugs and devices that have been approved or are applying for market in China are subject to this Regulation. The working procedure are summarized in the diagram below.</p>



<div class="wp-block-image"><figure class="aligncenter"><img fetchpriority="high" decoding="async" width="703" height="1024" src="https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939-703x1024.jpg" alt="" class="wp-image-2417" srcset="https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939-703x1024.jpg 703w, https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939-206x300.jpg 206w, https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939-768x1119.jpg 768w, https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939-600x874.jpg 600w, https://www.accestra.com/wp-content/uploads/2019/06/微信图片_20190624145939.jpg 1253w" sizes="(max-width: 703px) 100vw, 703px" /><figcaption>Working Procedure for Overseas Drug Inspection</figcaption></figure></div>



<p> And in the first half of 2019, there are 12 drug inspection notices published on the website of Center for Food and Drug Inspection, NMPA, among which 3 companies are given the penalty of sales suspension in China. However, the imported drug manufacturers still experienced a much lower inspection frequency comparing to local companies. Although this new regulation can be considered as a signal that China authority wants to treat foreign companies and domestic companies equally, before that they still have the staff shortage problem to solve. </p>



<div class="wp-block-image"><figure class="aligncenter"><img decoding="async" width="1024" height="502" src="https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159-1024x502.png" alt="" class="wp-image-2418" srcset="https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159-1024x502.png 1024w, https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159-300x147.png 300w, https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159-768x377.png 768w, https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159-600x294.png 600w, https://www.accestra.com/wp-content/uploads/2019/06/微信截图_20190624190159.png 1525w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption>Inspection Notice Published by Center for Food and Drug Inspection, NMPA </figcaption></figure></div>
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