• EU Falsified Medicines Directive Could Result in Drug Shortages

    The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.   The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing pr...
  • 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...
  • Brazil: Strike May Prompt Drug Shortages

    [Editor's note: the majority of Brazilian regulatory authorities ended their strike on Monday, 3 September 2012 according to Reuters . Approximately 10% of workers remain on strike.] The Brazilian press is claiming that the ongoing strike of employees at the country's National Health Surveillance Agency, Anvisa, is threatening to create drug shortages throughout the country.   "In the hospitals, concerns have grown over shortages of essential medicines an...
  • Brazil: New Drug and Device Import Rules Issued

    New import rules ( RDC 43 ) released by Brazilian regulatory authority Anvisa on 6 August clarify that products subject to regulation may obtain import approval if the import license application is not examined within five working days from the date of request by the importer.  The new rules cover situations where a labor strike-such as the one recently launched by many Anvisa regulators -or other event slows down the import administrative process or when th...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh

    South Korea is moving to quickly strengthen its import controls after encountering repeated attempts to smuggle in drug products containing the powdered remains of deceased human flesh, reports The Korea Times . "The Korea Customs Service (KCS) said it apprehended 29 smugglers, who disguising themselves as tourists and attempted to bring some 11,000 capsules into Korea in their luggage," wrote The Korea Times . "Six people used international parcels to smuggle in the m...
  • Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

    The state of Nebraska, engaged in an ongoing battle with the US Food and Drug Administration (FDA) over its supply of an controversial anesthetic drug used in executions, confirmed it will defy an FDA order to hand over remaining supplies of sodium thiopental, reports The Associated Press. In a statement released 20 April, Nebraska's state attorney general's office said they believed a court order, issued by Federal District Court Judge Richard Leon, was incorrect. Leon...
  • FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug

    The US Food and Drug Administration (FDA) is currently embroiled in an escalating fight with South Dakota's government over the regulatory quality-and legal status-of a drug intended to be used to put prisoners to death, reports KSFY News . The drug, an anesthetic known as sodium thiopental, is a staple of a three-drug cocktail commonly used to execute prisoners on death row. Anti-death pentalty advocates have increasingly been targeting the drug, which is no longer p...
  • Court Bars FDA from Importing Drug Used in Death Penalty

    A US District Court judge this week barred the US Food and Drug Administration (FDA) from importing an anesthetic drug used in executions, saying FDA's use of enforcement discretion was "callous" and "disappointing," reports Reuters . "The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the execution...
  • 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...
  • US FDA Importing Unapproved Drugs to Ease Shortages

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced at a press conference on 21 February that the agency is working with manufacturers to resolve drug supply shortages of the cancer drugs Doxil (doxorubicin) and methotrexate. Hamburg said the agency is working with domestic and foreign manufacturers to bring supply levels of both drugs back to non-shortage levels, adding that the agency has allowed the import of an unapproved replacement of Dox...
  • Inmates Sue Agency to Stop Import of Drugs

    Death row inmates incarcerated in Tennessee, Arizona and California argued on 9 February that the US Food and Drug Administration (FDA) is breaking the law by allowing the importation of sodium thiopental -an anesthetic drug commonly used in a cocktail of execution drugs-after its manufacturer halted domestic production of the drug in 2011. The inmates contend that FDA does not have the authority to allow the drug to be imported because the drug product does not have ma...