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  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...
  • Regulatory NewsRegulatory News

    FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs

    Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” The agency also published a table of the ranitidine and nizatidin...
  • Regulatory NewsRegulatory News

    EMA Lays Out Plans for Testing for Nitrosamine Impurities

    As potentially cancer-causing impurities have been identified in some blood pressure and heartburn medicines, the European Medicines Agency (EMA) is outlining a three-step process whereby manufacturers can identify and control nitrosamine impurities, including N-nitrosodimethylamine (NDMA). EMA on Monday released new templates for manufacturers to complete as part of their risk evaluations and confirmatory testing. By 26 April 2020, EMA is calling on companies to conduc...
  • Regulatory NewsRegulatory News

    FDA Warns Against Certain Methods for Testing Zantac for Carcinogen

    As the US Food and Drug Administration (FDA) continues to test ranitidine products, including the popular heartburn medicine Zantac, from multiple manufacturers for the carcinogen N-Nitrosodimethylamine (NDMA), the agency on Wednesday warned against the use of a particular testing method. “FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because ...
  • Regulatory NewsRegulatory News

    EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen

    Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidine medicines after tests showed that some contained the impurity. NDMA is classified as a substance that could cause cancer on the basis of animal studies, although EMA explains how it is present in some foods and in water suppl...