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  • Regulatory NewsRegulatory News

    EU Task Force to Implement New Drug Identification Standards

    The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs. The goal of the task force will be to develop a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards developed by the International Organization for Standardization (ISO). Background EMA recently issued an explanatory document titled Data submission of authorised m...
  • Regulatory NewsRegulatory News

    EMA Explains Centralized Product Database, Talks Future Changes

    The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA). In the document, the agency discusses the current status of its eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and talks about planned changes through 2016. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. ...