RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    The article discusses drug shortages in Germany the root causes of production problems with active pharmaceutical ingredients and drug product manufacturers. The authors offer analysis from a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active i...
  • Regulatory NewsRegulatory News

    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
  • Regulatory NewsRegulatory News

    UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

    Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be done. Chief among the issues that need to be dealt with is industry readiness for the new customs procedures under a no-deal Brexit and ensuring that industry registers to access new freight capacity. “The Government is establishing a dedicated trader readiness ‘Support U...
  • Regulatory NewsRegulatory News

    FDA: US Heparin Supply Not Impacted by African Swine Fever in China

    With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China. “The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.” The update from FDA follows a letter sent in ...
  • Regulatory NewsRegulatory News

    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
  • Regulatory NewsRegulatory News

    Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

    As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do. Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasin...
  • Regulatory NewsRegulatory News

    EMA on Brexit: Risk for Drug Shortages Decreases

    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”   The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized me...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Indian Court Rejects Abbott’s Plea to Stop Probe into Alleged Diabetes Cartel

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Posts Guidance on How to Manage and Communicate Drug Shortages   Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.   TGA proposed moving to a mandatory model in Apri...
  • Regulatory NewsRegulatory News

    More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

    The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid. The good news on Baxter comes as the agency said all other companies that were on an initial list of drugs considered at risk of potential shortages – because the drugs were largely or entirely...
  • Regulatory NewsRegulatory News

    FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

    Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria. The temporary imports are manufactured at Baxter facilities in Ireland and Australia and the company notes that at this time, "No other entity except Baxter is authorized by the FDA t...
  • Regulatory NewsRegulatory News

    EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit

    Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month. The comments follow the agency saying last week that it could lose between 19% and 94% of its staff depending on whic...