• RF Quarterly

    The ICH over the last 30 years: A personal reflection

    This article gives a personal reflection on the development of ICH since its inception in 1990 and during which time the author was involved both as a regulator and, more recently, an industry participant. The evolution of ICH is discussed as it has moved from an international organization involving three regions to a truly global body. The successes and the challenges are discussed, and consideration is given to future development.   Keywords – international harmo...
  • Regulatory NewsRegulatory News

    EU reference labs: Commission adopts implementing acts

    A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.   On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical ass...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS congratulates 108 spring RAC exam passers

    RAPS today announced that 108 professionals passed the Regulatory Affairs Certification (RAC) exams in the spring examination window, which occurred in March and April 2022. In doing so, these professionals have obtained their RAC-Drugs or RAC-Devices designation, the leading credentials for regulatory professionals in the healthcare product sector. These 108 individuals join more than 5,000 global professionals who hold RAC certifications. “On behalf of RAPS, I offe...
  • Feature ArticlesFeature Articles

    Five reasons to invest in a dedicated regulatory intelligence department

    This article presents some key points for consideration regarding the establishment of a dedicated and centralized regulatory intelligence department.   Keywords – centralized, dedicated department, regulatory intelligence   Introduction Regulatory intelligence has become an increasingly important component of regulatory affairs as the global landscape expands and changes, and professionals and businesses must adapt rapidly to remain current and viable. I...
  • Regulatory NewsRegulatory News

    MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).   The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, a...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Specialist vs. generalist, RI, and more

    Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence...
  • Feature ArticlesFeature Articles

    Strategic applications of regulatory intelligence

    Organizations require regulatory intelligence (RI) solutions now more than ever, especially in the current context of rapidly emerging technologies and evolving regulatory landscape. This article provides an overview of a three-part process of RI, consisting of data input, analysis, and output, and its strategic application in the product life cycle and business processes in achieving a competitive edge. RI has a significant range of applications and could be a practical ...
  • Feature ArticlesFeature Articles

    In-house regulatory database development: Solution for a competitive oncology landscape

    The unprecedented number of new investigational agents in clinical development in the competitive oncology space presents a significant challenge for regulatory intelligence professionals. Strategic decisions are complicated by the overwhelming amount of regulatory information scattered across numerous repositories. The development of an in-house database may facilitate success for businesses in the prevailing information-centric world. Effective implementation of an in-ho...
  • Regulatory NewsRegulatory News

    Excipient group releases guide on reporting microplastic use in pharmaceuticals

    The International Pharmaceutical Excipients Council (IPEC) has just released a how to guide to assist the pharmaceutical industry in complying with new labeling and reporting rules for microplastics that have been intentionally added to pharmaceuticals.   The document “summarizes the core elements of the restriction proposal and intends to provide guidance for excipient manufacturers and users on how to prepare for compliance,” IPEC announced.   The microplastics...
  • Feature ArticlesFeature Articles

    The leadership role in regulatory affairs

    Abstract  The global regulatory affairs (RA) profession is facing a shift in the definition of leadership success. This article aims to shed some light on important aspects of regulatory leadership. In the context of the article, leadership is defined by the power of making a difference. It explains why critical thinking, business acumen, emotional intelligence, team building, influence and mentorship plays a vital role in building leaders and why RA professionals today...
  • Regulatory NewsRegulatory News

    EU foresees reenergized clinical trial sector as new regulations take effect

    The delayed Clinical Trials Regulation (CTR) is set to take effect on Monday, 31 January, marking a milestone in the European Union’s attempt to improve transparency and boost the amount of human research that takes place in the region.   Currently, sponsors must file clinical trial applications to national regulators and ethics committees in each country that they want to include in their studies, then cope with multiple processes for registering their studies and pos...