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  • Regulatory NewsRegulatory News

    FDA Withdraws Guidance on Electronically Submitting Manufacturing Establishment Info

    The US Food and Drug Administration (FDA) last week withdrew draft guidance published in December 2016 on submitting manufacturing establishment information electronically. “After considering the public comments received, FDA has decided to withdraw the draft guidance and reevaluate its approach to submission of manufacturing establishment information in drug applications,” the agency said. Many of the comments on the draft guidance, which was intended to implement s...
  • Regulatory NewsRegulatory News

    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
  • Regulatory NewsRegulatory News

    FDA Pushes Back eCTD Deadline for Type III DMFs Again

    Ahead of the 5 May 2019 deadline set last April, as the required date for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format, the US Food and Drug Administration revised final guidance to reflect a new one-year delay on the implementation date. The sixth version of the final guidance for compliance with eCTD requirements was posted Tuesday to push the date back again after version 5 provided an extension from the previous...
  • Regulatory NewsRegulatory News

    FDA Offers New ICH Guidance on Organizing a CTD

    The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA. "A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic subm...
  • Regulatory NewsRegulatory News

    ICH Details Pilot Training Programs for 2017

    The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan. The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program. Under the pilot, the ICH Training Subcommittee has partnered with a small group of training p...
  • Feature ArticlesFeature Articles

    Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

    This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...
  • 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

    FDA Offers Technical Rejection Criteria for Study Data

    For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs). Technical rejection criteria is being added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines, FDA says. ...
  • 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...