• FDA Data Mining Project Proposal Once Again Withdrawn

    Earlier this week, Focus reported that a data mining project once abandoned by the US Food and Drug Administration (FDA) for lack of funding had been resurrected by the agency. Now, just days after the agency announced the project's return, it is once again cancelling the project-for now. Background FDA's data mining proposal has been in the works for more than a year. In April 2013, the agency established a notice indicating that it wanted to work with an outside com...
  • FDA Resurrects Data Mining Project Once Left for Dead

    The US Food and Drug Administration (FDA) has resurrected a once-canceled project intended to better mine data about adverse drug reactions from literature reports. Background FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and has regularly expressed a keen interest in methods of monitoring adverse event data. In April 2013, for example, it put out a notice indicating it wants a partner to help it bu...
  • EMA Calls for Greater Emphasis on Biomarkers, Genomics in Pharmacovigilance

    The European Medicines Agency (EMA) has released a new draft guideline intended to leverage pharmacogenomics in tracking and evaluating adverse events in products once they have received approval. Background Pharmacogenomics refers to the way in which different people are affected in different ways by the same drug, owing largely to their genetic composition. Some genes may cause a drug to be more potent than originally intended, while other genes may cause a drug to be...
  • EU Regulators Launch Vaccine-Focused Pharmacovigilance Project

    EU pharmacovigilance is expanding in a big way for vaccine products, the European Medicines Agency (EMA) has announced. Under a new plan unveiled on 26 November 2013, EMA will be working with other regulatory bodies on a new five-year project known as the Accelerated Development of Vaccine Benefit-Risk Collaboration in Europe ( ADVANCE ), the intent of which is to better assess the risks and benefits of a vaccine throughout its lifecycle. Unlike many drugs, vaccines are...
  • European Parliament Proposes Changes to Pharmacovigilance User Fee Collection System

    • 23 October 2013
    A new legislative draft report posted by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) on 18 October 2013 calls for changes to be made to the way in which user fees are payable to the European Medicines Agency (EMA) for some application filings. EMA, like the US Food and Drug Administration (FDA), partially funds its review work through user fees payable to the agency for many routine activities, such as the registratio...
  • European Commission Adopts Proposal for Pharmacovigilance Fees Payable to EMA

    The European Commission has today adopted a proposed regulation which would see pharmaceutical companies pay specific fees for EU-wide pharmacovigilance activities.  This is due to the recent legislation on pharmacovigilance applicable in the EU since July 2012, which significantly broadens the tasks of the European Medicines Agency (EMA), reinforcing its role as a hub for the coordination of the scientific resources made available by the Member States. Since t...
  • EMA to Conduct Safety Review of EU and Nationally Approved Drugs

    The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a drug contains. The review is slated to begin on 1 April 2013. Until now, the agency's review of the safety of marketed drugs has been limited to medicines authorized through the centralized procedure.  EMA's expanded authority to undertake such a review was granted ...
  • Feature ArticlesFeature Articles

    Assessing Benefits Versus Risks in Europe--the New Focus in Pharmacovigilance

    Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug's benefits outweigh its risks. 1 Due to the heterogeneity of the data under review (e.g., toxicological, efficacy and safety), all previous approaches usin...
  • Australia, New Zealand Propose Parallel Drug and Device Monitoring System

    In the latest collaboration since Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products, the two agencies have jointly opened a consultation on a proposed parallel process for an early warning system concerning the safety of medicines and medical devices. Each regulatory agency would identify drugs and devices with potential safety concerns through their exis...
  • New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA

    The European Medicines Agency (EMA) is looking to reduce the number of medication errors that take place in the EU through the formation of a new coordinated approach that could ultimately have regulatory implications, the agency announced. The proposal, which came out of an EMA workshop held for two days starting 28 February 2013, would specifically seek to improve the reporting of medication errors in the hopes that additional data could prove useful in preventing futu...
  • UK Recommends Amendments to EU Pharmacovigilance Directive

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has submitted recommendations to the European Commission to amend the recently implemented EU pharmacovigilance legislation.  In a January 16 letter to the European Commission's Health and Consumers Director General, MHRA recommended changes to patient information that would: Enable patients to get most important information first and then allow them to drill down into more detail as needed....
  • RAPS' LatestRAPS' Latest

    Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball

    Chapter 15 Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." 1 Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment. 2 The main methods for pharmacovigilance are randomized trials,...