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  • Regulatory NewsRegulatory News

    EMA Mid-Year Report: Fewer New Non-Orphan Drugs, More GMP Inspections

    The European Medicines Agency's (EMA) mid-year report, detailing the agency's activities through 30 June 2015, reveals that the agency met or was ahead of most metrics covered, despite a decline in the number of new non-orphan drugs and a sharp rise in the number of GMP inspections conducted. Rating System EMA uses a four-colored "traffic light" system to rate its workload and performance against its forecast goals. Depending on the result for each indicator, the agency...
  • Regulatory NewsRegulatory News

    EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

    Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...
  • Regulatory NewsRegulatory News

    Tufts CSDD Raises Questions over Adverse Event Reporting in US

    Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday. Background FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, m...
  • Feature ArticlesFeature Articles

    Managing Pharmacovigilance in Digital Health Initiatives

    • 14 August 2015
    This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives. The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among...
  • Regulatory NewsRegulatory News

    FDA and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...
  • Regulatory NewsRegulatory News

    FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

    The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically. Background The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements . While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has tra...
  • 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...
  • Regulatory NewsRegulatory News

    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
  • 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

    FDA Finalizes Lot Distribution Report Guidance With Few Changes

    New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed. Background As required by  21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted...
  • Regulatory NewsRegulatory News

    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...