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  • Regulatory NewsRegulatory News

    Swissmedic To Prioritize Electronic Adverse Events Reports

    Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports. According to Swissmedic, the number of ADRs received has grown in recent years, driven primarily by growth in the number of reports submitted by drugmakers. The agency also says it expects the upward trend to continue, in part due to the recent revision to Switzerland's Ther...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

    The European Medicines Agency (EMA) is making it easier for patients and industry to keep track of adverse events associated with medicines authorized for use by EMA and other national drug regulatory authorities. Under a massive expansion of EMA's existing ADRreports.EU website, which houses the European database of suspected adverse drug reaction (ADR) reports, consumers can now view suspected ADR reports for drugs regardless of their centrally authorized approval st...
  • Regulatory NewsRegulatory News

    Australia’s TGA Launches Web-based ADR Reporting

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers. The new web-based reporting service is one of a range of TGA initiative...
  • Brazil Launches New Adverse Event Reporting System

    Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products.  Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form The Municipal Hospital of Cuiab&aacu...
  • EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies

    The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...
  • EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

    The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators. The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection ...
  • New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency

    The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area (EEA) through a brand-new website. The website, www.ADRreports.eu , is linked up with EMA's EudraVigilance adverse event reporting database and already contains information on more than 650 medicines authorized through the centralized procedure. Each report on the w...