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Worldwide Regulatory Updates

November 3, 2019

United States

  • November 3: A new report from the US Food and Drug Administration (FDA) Drug Shortages Task Force outlines the major causes of drug shortages and recommends steps the FDA and the pharmaceutical industry can take to combat this growing problem. The root causes of shortages often involve economic factors driven by both private and public-sector policies, according to the report.

European Union

  • November 3: The European Medicines Verification Organization (EMVO) announced that in the event of a no-deal Brexit, onboarding partners (OBPs) can continue to upload data to the European Medicines Verification System in the same manner they are currently using.
  • November 3: SecurMed, the nonprofit organization that delivers the Medicines Verification System for the UK, and supply chain consulting firm Excellis Health Solutions published practical suggestions for manufacturers and dispensers on how to manage packs exported from India, which often conflict with EU FMD requirements and have been generating false alerts.

Russia

  • November 3: Russia’s State Duma published an amendment proposal to request a six-month transition period for the implementation of product marking and reporting regulations. No final decision has been made.

Egypt

  • November 3: Egypt’s Ministry of Health and Population later this month will announce a new pilot phase for the country’s track and trace program. As part of the announcement, which is planned for November 15, the Ministry will publish the next version of technical guidelines. The pilot is planned to run for two weeks, with a December analysis period and a potential announcement by the end of the year about new timelines for compliance.
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