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  • Regulatory NewsRegulatory News

    FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

    The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVI...
  • Regulatory NewsRegulatory News

    FDA Expands Generic Drug Priority Reviews

    Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue. The progress comes as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. "Earlier this year we made changes to how we pri...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Pilots Changes to Accelerate Drug Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year be...
  • Regulatory NewsRegulatory News

    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
  • Regulatory NewsRegulatory News

    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
  • Regulatory NewsRegulatory News

    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...
  • Regulatory NewsRegulatory News

    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...
  • Regulatory NewsRegulatory News

    New Research Compares Drug Regulators Around the Globe

    Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. Of the regulators in the more established major pharmaceutical markets (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such mark...
  • Regulatory NewsRegulatory News

    Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

    A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits. The study, conducted by Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health and three of his colleagues at Tufts Medical Center, compared the change in quality-adjuste...
  • Feature ArticlesFeature Articles

    Conditional Approvals for Early Access to New Medications

    This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US. Introduction Before a medicinal product for human use is authorized to enter the market, it must undergo extensive study to ensure its s...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...