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  • Regulatory NewsRegulatory News

    Researchers Pilot Ingestible Electronic Sensor to Monitor Microbiome

    Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics . The ingestible sensors used in the trial can sense oxygen, hydrogen and carbon dioxide by using a combination of thermal conductivity and semiconducting sensors, the researchers said,...
  • Regulatory NewsRegulatory News

    FDA Looks to Standardize PQ/CMC Data and Terminologies

    The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

    The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...
  • Regulatory NewsRegulatory News

    Health Canada to go eCTD-only for Drug Applications

    Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. The agency also notes that sponsors can request an exemption from the requirement for individual products, but sa...
  • Regulatory NewsRegulatory News

    FDA Delays eCTD Requirements for Master Files

    The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018. Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and...
  • Regulatory NewsRegulatory News

    May Deadline for FDA's eCTD Transition Approaches

    Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) using the electronic Common Technical Document (eCTD). Drug Master Files (DMFs), Biological Product Files (BPFs)...
  • Feature ArticlesFeature Articles

    Strategies for Smarter Compliance in a Technology-Driven FDA Environment

    The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance. Introduction Come May 2017, the US Food and Drug Administration (FDA) will no longer accept submissions of drug applications that do not follow the electronic Common Technical Document (eCTD) format. This signifies further movement toward the use of technology in regulatory approvals and a key milestone in the modernizat...
  • Regulatory NewsRegulatory News

    Electronic Informed Consent: Final Q&A Spells Out New Recommendations

    The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products. The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure prote...
  • Feature ArticlesFeature Articles

    China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications

    This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs. Introduction Earlier this year, the China Food and D...
  • Regulatory NewsRegulatory News

    Regulatory Focus Features Recap: July 2016

    Feature articles for July focused on managing regulatory information and systems and eCTD submissions. The regulatory industry is being challenged by the increasing complexity and rate of change associated with compliance related requirements, while also focusing on improving the efficiency of operations across the enterprise. For regulatory professionals, effective management of information and content is critical to managing interactions with health authorities on a ...
  • Feature ArticlesFeature Articles

    eCTD: Journey Through the Decade

    This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management . Overview The eCTD was developed in 2003 by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 E...
  • Feature ArticlesFeature Articles

    Accelerating Global Submissions with a Six-Point eCTD Strategy

    This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise. The World - and Sponsor Challenges - are Gettin...