China National Medical Products Administration (NMPA) announced the suspension of importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China on March 25, 2020. Celgene, now a Bristol-Myers Squibb company, supplied the product to BeiGene. The suspension is the penalty as part of the overseas inspection findings at B-MS’ contract manufacturing facility of Fresenius Kabi in the USA.
In order to ensure drug/medical device safety, NMPA’s effort on overseas inspection has been increasing in recently years. On December 28, 2018 NMPA issued the Guideline on Overseas Inspection for Drugs and Medical Devices (link HERE) to standardize the overseas inspection of drugs and medical devices.
From 2011 to 2019, the overseas production sites of 171 drugs were inspected and 22 of them were suspended for importation based on the inspection findings. Since 2020, NMPA has issued on-site inspection notices for 8 products produced overseas. On Mar. 23, chlorpheniramine maleate manufactured by Supriya Lifescience, an Indian pharmaceutical company, was suspended for importation, sales and use in China too, based on the inspection results.
For our webinar on overseas inspection, click HERE.
For RAPS article about overseas inspection in China, please click HERE.
To assess whether you are compliant with NMPA requirements, please email info@ChinaMedDevice.com.