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Worldwide Regulatory Updates

November 18, 2018

TraceLink continuously monitors emerging and evolving track and trace regulations around the world. View updates from the past week, and other recent developments below.

China

  • The Government published a new rule on Chinese Vaccine Management for public commentary, which is related to the previous pharmaceutical traceability project. The government would like to develop a vaccine traceability system and is seeking input on data elements and an information sharing model.
  • The National Medical Products Administration has launched a new website for information sharing with the public and stakeholders. The first piece of information published on the site was a summary of the previous guidance for the forthcoming medicine traceability system.

European Union

  • EMVO issued an on-boarding status report as of October 2018. At that time there were: 1,062 Onboarding Partners (OBPs), 935 signed participation agreements, 786 legitimacy checks passed, 548 connected to the Quality Environment (IQE), 293 connected to the Production Environment (PRD), and 64 uploading master data.
  • EMVO published a "Letter of Adhesion" to be signed by OBPs. This letter contained a set of conditions for non-EEA OBPs that are related to data handling and the ability of EMVO/NCAs to audit their processes.
  • The MHRA ramped up EU FMD communication to all supply chain stakeholders, most notably regarding end-to-end EU FMD guidance and system error handling guidelines for end users. These topics were shared in this week's National Medicines Verification System (NMVS) and EU FMD TraceLink Life Sciences Cloud Community Special Interest Group sessions.
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