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  • Regulatory NewsRegulatory News

    EU Looks to Improve Data Quality of mHealth Apps

    The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health. The working group comes as such lifestyle and well-being mHealth (everything from step trackers to heart rate analyzers to weight-loss helpers) has skyrocketed to more than 100,000 apps...
  • Regulatory NewsRegulatory News

    How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains

    The US Food and Drug Administration (FDA) is looking to shed more light on cases where two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements. According to the draft guidance, the term convenience kit, which the guidance attempts to adjust, “applies solely to two or more different medical devices packaged together for the convenience of the user where they...
  • Regulatory NewsRegulatory News

    EMA Outlines High-Level Strategy for Next Five Years

    Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020. The new plan, unveiled Friday, offers 16 objectives around four themes: Contributing to human health, contributing to animal health and human health in relation to veterinary medicines, optimizing the operation of the network and contributing to th...
  • Feature ArticlesFeature Articles

    A Brighter Future for Regulatory Professionals

    • 15 December 2015
    • By
    Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China. After a career as a researcher at the Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention (China CDC), Bird Shi became a regulatory affairs director at one of the world's top 500 enterprises. She has witnessed how the regulatory system of China's food industry has improved since its founding and although regulatory affa...
  • Regulatory NewsRegulatory News

    Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

    India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Looks to Further Prevent Medication Errors (3 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Adopts Batch of Documents Aimed at Preventing Medication Errors The European Medicines Agency (EMA) has adopted a handful of guidance documents designed to prevent the occurrence of medication errors. In the documents, EMA outlines the best practices for minimizing risk, how to code and assess errors and specific concerns relating to insulin and other diabetes medicin...
  • Regulatory NewsRegulatory News

    Human Gene Editing, CRISPR and FDA: How Will They Mix?

    A number of the world’s top scientists, policy experts and bio-ethicists met this week in Washington, DC to discuss the implications of human gene editing, and though the focus of the summit was centered more on ethical considerations than regulations, opinions flew on Wednesday over how some new technologies will likely be regulated. Background As Jennifer Doudna, a molecular and cell biologist at University of California, Berkeley, and a leader in the field notes in a...
  • Regulatory NewsRegulatory News

    Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches

    As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...
  • Regulatory NewsRegulatory News

    IMDRF Sets New Long-Term Priorities on Pre-Market Review, Post-Market Surveillance of Devices

    The International Medical Device Regulators Forum (IMDRF) says its focus over the next four years will be to hone in on the convergence of regulations across jurisdictions, and in supporting innovation and timely access to safe and effective medical devices, according to a strategic plan unveiled earlier this month. The forum's management committee has also identified two new areas where it plans to focus its work: enhancing post-market surveillance and improving the eff...
  • RAPS' LatestRAPS' Latest

    Can Some Medical Devices Skip China's Clinical Trial Mandate?

    In October 2014, the China Food and Drug Administration (CFDA) implemented its new medical device regulations, including new clinical trial requirements and associated submission processes. To market higher-risk products—those designated as class II or III under the Chinese classification system—the device must undergo a registration process that also may require clinical trials be conducted. Foreign device manufacturers need to understand that if clinical tr...
  • Regulatory NewsRegulatory News

    FDA Planning Six New Drug, Device Regulations for 2015

    The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development. Background The list, known as FDA's "Unified Agenda," is published bi-annually as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. While the list is intended to serve as an overview of the agency's planned actions for a given year, in practice just a s...