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  • Regulatory NewsRegulatory News

    EU's New Centralized Pharmacovigilance Portal Gets Endorsement from EMA

    A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed. Background In January 2015, EMA announced the launch of a central repository , hosted on the eSubmissions website, for submitting periodic safety update reports (PSURs). In the EU, drugmakers are required to submit PSURs to EMA at regular intervals. These reports are evaluated and used to en...
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    EMA Issues Recommendations for Veterinary Pharmacovigilance, Signal Detection

    The European Medicines Agency (EMA) has released a new set of recommendations for postmarket surveillance for veterinary medicinal products, which will go into effect on 1 October 2015. Background Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. For veterinary populations, regulators, companies and veterinarians are responsible for monitoring drugs and reporting suspected adverse drug reactions (ADRs). This information ...
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    How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

    In an effort to improve how safety issues are communicated, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey for healthcare professionals to provide input on how the communications are used. Background The survey is being launched as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action initiative, which was launched to "help medicines regulators operate pharmacovigilance systems...
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    EMA to Monitor Select Medical Literature for Drug Side Effects

    The European Medicines Agency (EMA) is launching a new initiative to monitor selected medical literature to proactively identify suspected adverse drug reactions (ADRs) for some 400 active substances. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected ADRs. This informati...
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    EMA Says Companies Still Need to Report Side Effects of Donated Drugs

    Drug makers are frequently involved in relief and humanitarian aid efforts, often through donating their products. However, in light of recent outbreaks of neglected tropical diseases such as Ebola, the World Health Organization (WHO) has asked the European Medicines Agency (EMA) to clarify its drug safety monitoring requirements for companies that donate medicines outside the EU to treat neglected tropical diseases. According to WHO, neglected tropical diseases are a...
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    WHO Makes Drug Side Effects Easier to Find With New Database

    Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess. Background The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting re...
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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...
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    EU Committee Confirms Increased Risk with Ibuprofen at High Doses

    A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues. Background Ibuprofen belongs to a class of drugs, called non-steroidal anti-inflammatory drugs (NSAIDs), which includes drugs such as diclofenac, naproxen and aspirin. NSAIDs already have a warning about increased risk of blood clots included in the information distributed with such products ...
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    UK Regulators Detail Most Common Pharmacovigilance Deficiencies in New Report

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has released statistics on the pharmacovigilance inspections it conducted between April 2013 and March 2014. While the figures continue a similar trend from previous years, MHRA says the impact of new EU pharmacovigilance legislation can be seen in the data. Findings Compared to Previous Years One of MHRA’s responsibilities is to ensure that companies have proper systems in place for m...
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    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. ...
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    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
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    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...