• China: New Labeling Requirements for Imported Devices

    Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September. The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the r...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • China: Deadlines Established For Opthalmic GMP Implementation

    The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...
  • FDA In Process of Translating Many Publications, Guidances

    The US Food and Drug Administration's (FDA) Associate Commissioner for International Programs, Mary Lou Valdez, said in a statement the agency is working to translate many publications into different languages in order to help its foreign regulatory counterparts. In FDA's 11 April statement, Valdez notes the Office of International Programs (OIP) is "committed to supporting the agency's efforts to become a regulatory agency with a truly global reach." As a result, OIP i...
  • Chinese Suppliers Tied to Tainted Heparin

    • 23 February 2012
    Fourteen Chinese companies have been linked to contaminated heparin, an anticoagulant commonly used during surgical procedures and dialysis, according to a Wall Street Journal report . The US Food and Drug Administration (FDA) added these companies to an import list allowing FDA to stop shipments at the border. That list already included eight other Chinese suppliers who were believe to have provided tainted raw materials for the making of heparin. The Wall Street J...
  • Guidance for Industry on Heparin Released by FDA, Bookend to Heparin Scandal

    The US Food and Drug Administration (FDA) released new draft guidance for industry on ensuring that a company's heparin supply meets quality standards. The draft guidance, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality , comes just four years after tainted Chinese-sourced Heparin killed dozens of US citizens. The draft guidance aims to "help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repacker...