• Regulatory NewsRegulatory News

    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...
  • Feature ArticlesFeature Articles

    The ASEAN harmonization of technical standards on health supplements – An industry perspective

    Many countries in the Association of Southeast Asian Nations (ASEAN) require registration of health supplements, which generally takes a few months to years. There have been many different interpretations of the principle-based standards or regulations among the ASEAN member nations, making right-first-time regulatory submissions for the region hard to achieve and, absent defined review limits (such as rounds of questions/letters of deficiencies), lead times for approvals ...
  • Feature ArticlesFeature Articles

    The transition to ICH M10 and its impact on global submissions

    With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...
  • RF Quarterly

    RF Quarterly, June 2021: Artificial intelligence in global regulatory practice

    Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role of artificial intelligence (AI) in healthcare and its impact on global regulatory practice.   Advances in AI technologies are transforming healthcare delivery and hold promise for improving patient outcomes. However, these complex technologies have introduced new challenges, especially aroun...
  • Feature ArticlesFeature Articles

    MDR scope extension with human tissue: Regulatory implications and concerns

    Human tissue is newly introduced to the scope of the EU Medical Device Regulation (EU MDR). Although it offers the opportunity for uniform market access of device/tissue products, lack of clarity and borderline challenges remain and are centered on linking a harmonized device framework with a nonharmonized human tissue framework. Concerns include a shortage in the number of available notified bodies, decentralized regulatory oversight for tissues, and absence of an “Articl...
  • 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...