• 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

    Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015)

    Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia . Fresh Batch of Withdrawals and Rejections Chips Away at CFDA Backlog China Food and Drug Administration (CFDA) has wiped almost 150 drug filings from its backlog. Most of the applications were pulled by the companies themselves, with CFDA only actively rejecting 13 of the submissions. The withdrawals affected 131 filings by 82 companies. CFDA put pressure on companies ...
  • Feature ArticlesFeature Articles

    US Preparedness for Public Health Emergencies: Medical Countermeasures and Emergency Use Authorization

    This article discusses how medical products needed during public health emergencies can be made available to the public through the use of FDA's Emergency Use Authorization (EUA). During public health emergencies, the US government must respond quickly. Medical countermeasures (MCMs) are medical products, such as drugs, vaccines and diagnostic tests needed during an emergency. MCMs are developed, manufactured, procured, stockpiled and distributed to protect or treat th...
  • Regulatory NewsRegulatory News

    EMA Spells Out New Expectations for Adaptive Pathways Applications

    The European Medicines Agency (EMA) has issued a new guidance to help companies applying to its adaptive pathways pilot. Background EMA launched its adaptive pathways pilot in 2014 to speed access to new medicines in areas of "high medical need" by leveraging existing approval pathways to support "early and progressive patient access" to new medicines. Under the pilot, drugs would either be authorized conditionally or in a staggered fashion by narrow indication befor...
  • Regulatory NewsRegulatory News

    EMA Issues Draft Guidance on Post-Authorization Efficacy Studies

    The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstanc...
  • Regulatory NewsRegulatory News

    Report: Competition Quickly Follows First-In-Class Approvals

    By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development. The study, which compared 40 drug classes with a first-in-class approval between 1998 and 2011, found that the race for marketing approval for new classes of drugs and biol...
  • Regulatory NewsRegulatory News

    EMA Sets Up Two-Year Pilot Program on Patient Registries

    The European Medicines Agency (EMA) has launched an initiative focused on existing patient registries, with the aim of seeing how they can be better used as a source of post-authorization data, and how they can help to establish new registries. Background EMA defines a registry as a system using observational methods over time to collect uniform data on a population defined by a particular disease, condition, or exposure. A disease registry includes patients bas...
  • Regulatory NewsRegulatory News

    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
  • Regulatory NewsRegulatory News

    EMA Hopes to Boost Drug Safety in Scientific Advice Pilot

    In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS). Background Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines. The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate rob...
  • Regulatory NewsRegulatory News

    Lingering Questions About Medical Apps

    In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory framework emerges for digital medicine," a commentary appearing in Nature this week, raise several regulatory challenges remaining unanswered. Background Since gaining oversight of medical devices through the passage of the Medical Device Amendments of 1976 , the US Food a...
  • Regulatory NewsRegulatory News

    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
  • Regulatory NewsRegulatory News

    FDA Releases Guidance for Clinical Trial Sponsor-Investigators

    New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial. As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often do not have the reg...