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NMPA Issued the Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim)
2019-12-20
NMPA has organized the formulation of the Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim), which was released on December 20, 2019.
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Gore and Tongren voluntarily recall hydrophilic coated guiding sheath
2019-12-19
Due to labeling mistakes, the manufacturers Gore Industrial Products Trade (Shanghai) Co., Ltd and Tongren Co., Ltd initiated the voluntary recall of specific batches of hydrophilic coated guiding sheath.
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Howmedica Osteonics Corp. voluntarily recalls hip joint prosthesis-polyethylene lining
2019-12-19
Due to the lack of locking metal wire on particular batches of hip joint prosthesis-polyethylene lining, the manufacturer Howmedica Osteonics Corp. initiated the voluntary recall of the product. The recall is identified as a Class III recall.
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Siemens Healthcare Diagnostics Inc. voluntarily recalls High Sensitivity C Reactive Protein Calibrator (hsCRP CAL)
2019-12-19
Due to discrepancy in the testing results of particular batches of High Sensitivity C Reactive Protein Calibrator (hsCRP CAL) which cannot be identified in quality control, the manufacturer initiated the voluntary recall of the product.
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NMPA issues announcement on the adoption of 13 ICH safety guidelines (NMPA Announcement No. 89 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 13 ICH safety guidelines, including S1A: Need for Carcinogenicity Studies of Pharmaceuticals.
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NMPA announces adoption of 15 ICH efficacy guidelines (NMPA Announcement No. 88 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 15 ICH efficacy guidelines, including E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions.