• Regulatory NewsRegulatory News

    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
  • Feature ArticlesFeature Articles

    Plain Language Labelling Requirements

    This article describes the requirements of the guidance document published by Health Canada on plain language labelling. The Regulations Amending the Food and Drug Regulations ( Labelling, Packaging and Brand Names of Drugs for Human Use ) came into force on 13 June 2015. 1 The Plain Language Labelling amendments aim to improve the safe use of drugs and help reduce preventable harms from medication errors by making drug labels and safety information easier to read and...
  • Regulatory NewsRegulatory News

    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
  • Regulatory NewsRegulatory News

    The Biggest Challenge for Regulators That No One's Talking About: Translation

    Regulators have long been concerned with the safety, efficacy and quality of the products they regulate. Now they have a new concern to think about: language. South Korea's healthcare products regulator is learning that lesson this week after being called out by The Korea Times for failing to keep its English-language website up to date. But as a review by Regulatory Focus shows, it's hardly the only regulator struggling to translate its documents in a timely manner...
  • Legislation Introduced to Require 'Plain Writing' for all Regulations

    The US Food and Drug Administration (FDA) could be statutorily required to use "plain writing" in all of its future regulations if a piece of proposed legislation has its way. The proposed bill, The Plain Writing Act for Regulations of 2012 , would "require that Federal regulations use plain writing to enhance public understanding of regulations" in the hopes that such language would "increase the level of public participation in the rulemaking process." The bill, intr...
  • FDA In Process of Translating Many Publications, Guidances

    The US Food and Drug Administration's (FDA) Associate Commissioner for International Programs, Mary Lou Valdez, said in a statement the agency is working to translate many publications into different languages in order to help its foreign regulatory counterparts. In FDA's 11 April statement, Valdez notes the Office of International Programs (OIP) is "committed to supporting the agency's efforts to become a regulatory agency with a truly global reach." As a result, OIP i...