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  • India to Require Notification of Foreign Drug Import Alerts

    Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI). The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on ...
  • Japan Joins Switzerland, Australia on List of Countries With API Quality Standards Equal to EU

    On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions. ...
  • China Announces Electronic Monitoring Deadlines for Imported Drugs

    The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must comply with electronic monitoring requirements by the end of November 2013, and all other imported drugs by the end of March 2014. The implementation of electronic monitoring is to be done in accordance with the former State Food and Drug Administration notice "on the issuance...
  • 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...
  • FDA Publishes List of all Device Guidance Documents Planned for 2013

    The US Food and Drug Administration (FDA) has published a list of 23 medical device guidance documents it plans to publish during fiscal year 2013, part of the recently passed FDA Safety and Innovation Act (FDASIA) . Among FDASIA's numerous provisions is the Medical Device User Fee Act (MDUFA) , which established the fees and regulatory expectations for the medical device review process. As of right now, those processes largely exist in the abstract, awaiting further...
  • Countries Responsible for EU-wide Safety Monitoring Announced

    The European Medicines Agency (EMA) published on 5 October 2012 the first list of EU member states responsible for monitoring the safety of specific active substances across the EU.  In effect, each listed country will be responsible for monitoring specific medicinal products that have been approved for marketing in more than one EU member state through either the national, mutual recognition or decentralized procedures.  The monitoring data that each coun...
  • 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...
  • China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

    China's State Food and Drug Administration (SFDA) issued new regulations on 15 August instructing provincial governments to publish on their websites so-called Black Lists of drug and device companies that engage in counterfeiting and related illegal activities.   The websites are to include the name of the company, its business address, the name of the legal representative or responsible person, and the individual's title.  Violations that would justify...
  • 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...