• Regulatory NewsRegulatory News

    GVP: EMA consults on revised risk minimization module

    The European Medicines Agency (EMA) on Wednesday released draft versions of the third revision to its good pharmacovigilance practice (GVP) module XVI guideline on risk minimization measures and its second addendum to the guideline on methods for evaluating the effectiveness of risk minimization measures for public consultation.   The deadline to comment on the documents is 28 April 2021 and EMA says it expects the revised guideline and new addendum to come into effect...
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    EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted

    The European Commission (EC) and European Medicines Agency (EMA) say their combined efforts have resulted in improved drug safety monitoring since new legislative requirements went into effect in 2012, according to a report released by the EC on Monday. "The analysis shows that the new system has been successful at detecting safety issues more quickly, thus enabling regulators to take rapid action when needed and provide advice and warnings to users of medicines," EMA wr...
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    EMA Releases Draft Guides to Reduce and Report Medication Errors

    To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors. Medication errors are mistakes made when prescribing, dispensing and administering medicine. The agency says these errors are the "most common preventable cause of undesired harmful effects" related to medicine in the EU. According to EMA, these errors have...
  • Additional Pharmacovigilance Guidelines Released by EMA

    The European Medicines Agency (EMA) has released its final two guidelines on good pharmacovigilance practices (GVPs) after releasing seven similar GVP guidelines on 22 June. The final two guidelines address modules III and X of proposed GVPs: pharmacovigilance inspections and additional monitoring, respectively. The first guideline, Pharmacovigilance Inspections , provides guidance on planning, conducting, reporting and following-up on pharmacovigilance inspections i...
  • EMA Finalizes Pharmacovigilance Practice Guidelines

    The European Medicines Agency (EMA) has released seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be-implemented pharmacovigilance (PV) legislation, which comes into effect 2 July 2012. The modules cover a variety of topics, including PV systems, PV quality systems, risk management systems, PV system master files, Periodic safety update reports (PSURs), postmarketing safety studies and advers...