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  • Regulatory NewsRegulatory News

    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
  • Regulatory NewsRegulatory News

    WHO Details Plan to Combat Antimicrobial Resistance Globally

    The World Health Organization (WHO) finalized a report on combating antimicrobial resistance (AMR), stressing the urgency to act. The final report—developed by the Interagency Coordination Group on Antimicrobial Resistance (IACG)—identifies 14 recommendations centered on the urgency and action needed for a global fight against AMR. “The challenges of antimicrobial resistance are complex and multifaceted, but they are not insurmountable,” WHO said, arguing the report’...
  • Regulatory NewsRegulatory News

    IMDRF Takes Another Stab at IVDs, MDSAP

    Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    IMDRF Works to Speed Entry of Devices Across Multiple Countries

    The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions. The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010. The MDCE WG’s consultation documents seek to reflect the recently implemented and/or ...
  • Regulatory NewsRegulatory News

    COCIR Pushes to Harmonize Device Standards

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of medical device standards. COCIR’s position paper set forth six recommendations on harmonizing device standards, citing an array of existing challenges such as the assessment process and the fixed publication schedule. Harmonized standards need revision to reflect changes to and increased regul...
  • Regulatory NewsRegulatory News

    EU MedTech Industry Signals Need for Harmonized Approach to Cybersecurity

    EU’s medical technology trade association on Wednesday issued new recommendations to ensure a harmonized approach on medical devices and digital health technology cybersecurity. The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) developed a set of seven recommendations to EU authorities to help guide a harmonization strategy for cybersecurity in line with security requirements set via new or forthcoming legislative...
  • Regulatory NewsRegulatory News

    CDRH Proposes New IMDRF Work Item on Standards

    Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program. Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF s...
  • Regulatory NewsRegulatory News

    ICH Advances Revised Guideline on Elemental Impurities

    The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for...
  • Regulatory NewsRegulatory News

    AdvaMed Responds to Senator’s Call to Advance Cybersecurity

    Responding to a letter from Sen. Mark Warner (D-VA) that called for a collaborative effort to advance cybersecurity in health care, medical device industry group AdvaMed sought to ease concerns about the impact of cyber attacks with updates on industry and regulators’ moves in line with its five principles. The industry trade association’s board of directors adopted the set of five medical device cybersecurity principles in 2017 to drive best practices across its member...
  • Regulatory NewsRegulatory News

    IMDRF Explains How to Build Submissions Using its Table of Contents Structure

    The International Medical Device Regulators Forum (IMDRF) issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents (ToC) structure, including harmonized technical guidelines on the acceptable folder structure and file format(s) for ToC-based submissions. The final guide was posted on Wednesday after IMDRF convened in Moscow—Russian regulators are currently chairing IMDRF—for a three-day open stakeholders forum that kicked off...