• Regulatory NewsRegulatory News

    EU MAHs Will See Relief on Some Pharmacovigilance Updates

    Beginning 1 February, drug companies operating in the EU will only have to update a database for some pharmacovigilance changes and will no longer have to submit a particular IA variation to the European Medicines Agency (EMA). According to the update from the European Commission on Friday, marketing authorization holders (MAH) have to inform competent authorities about changes to the Qualified Person responsible for Pharmacovigilance (QPPV) including contact details and...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions. PRAC, a part of the European Medicines Agen...
  • Regulatory NewsRegulatory News

    European Commission to Evaluate EMA’s Fee System

    Late next year, the European Commission will begin reviewing the pharmaceutical company fee system that helps fund the European Medicines Agency (EMA). “The effectiveness and the efficiency of the system will be examined notably with respect to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, including the remuneration paid by EMA to rapporteurs and experts from national competent authorities,” the commission sai...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Offers New Pharmacovigilance Updates (17 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases More Pharmacovigilance Documents The European Medicines Agency (EMA) has released a batch of draft pharmacovigilance documents. EMA covers multiple aspects of good pharmacovigilance practice (GVP) in the texts, from changes to a template for direct healthcare professional (HCP) communication, to tweaks to a biologics-focused document. In total, EMA pub...
  • Regulatory NewsRegulatory News

    EMA Takes a Firmer Stance on GCP Non-Compliance

    Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...
  • Regulatory NewsRegulatory News

    US Government Agencies Crack Down on Dietary Supplement Manufacturers

    In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-bas...
  • Regulatory NewsRegulatory News

    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
  • Regulatory NewsRegulatory News

    EMA Recommends Suspending Medtronic's Inductos Over GMP Issues at CMO

    The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures. The recommendation comes after a follow up inspection of a US manufacturing site was found to be "non-compliant with manufacturing requirements [and] did not have adequate measures in place to prevent particle contamination." While EMA notes...
  • Regulatory NewsRegulatory News

    Updated: MHRA Suspends UK Company's MS License

    Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US. The MHRA did not reveal what caused it to suspend Bionical Limited's license , but according to MHRA's most recently updated list of suspensions, the license is suspended until 18 February 2016. Jonathan Hughes, business development director of Bionical, told RAPS that the suspension c...
  • Feature ArticlesFeature Articles

    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
  • 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

    MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is considering conducting "stand-alone" inspections of companies that conduct pharmacovigilance activities on a contractual basis for drugmakers. Background 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 adverse events. This infor...