• RF Quarterly

    Elements of global regulatory strategy — The basics

    For most of regulatory science’s established history, regulations governing drug safety and efficacy were established on a country-by-country basis. For instance, a US-centric framework was appropriate when most US-manufactured drugs were distributed and sold largely on the US market. Today, the pharmaceutical industry’s expanding global reach means drug distribution is multinational, yet the current regulatory frameworks still are largely national or regional in focus. Th...
  • RF Quarterly

    An introduction to regulatory strategy

    In its simplest form, strategy can be considered bringing a new product to market, but it touches every product development lifecycle aspect and can ensure market sustainability. A limited or inadequate strategy can challenge global expansion, thus emphasizing the importance of a well-designed and executed regulatory strategy. This article identifies the requirements for developing a strategy for a drug development plan, as well as postmarketing strategy, with some global ...
  • RF Quarterly

    Application of project management strategy to postapproval CMC submissions

    The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to PMBOK. This article presents opportunities for using a project management framework when strategizing for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and t...
  • RF Quarterly

    Medical writing strategies: Aligning regulatory documents with strategic goals

    This article provides some best practices to align regulatory documents with strategic goals, allowing regulators to understand what a sponsor is trying to achieve, why this goal is important, and how the totality of available information supports the desired regulatory action. Adopting the perspective of a regulatory agency audience, using clear structure and language, and leading teams skillfully are key elements of successful regulatory medical writing.   Keywords ...
  • Feature ArticlesFeature Articles

    FINALIST New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
  • Regulatory NewsRegulatory News

    EU adopts 10-part workplan to guide the acceleration of clinical trials

    The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a larger workplan to  accelerate the adoption of clinical trials in the EU. The priorities are meant to steer the agencies’ work from 2022-2026.   The workplan was adopted under the auspices of the EC-HMA-EMA initiative Accelerating Clinical Trials in the EU (ACT EU), which launched earlier this year. (RELATED: EU launch...
  • Regulatory NewsRegulatory News

    EU issues long-awaited GMP Annex 1 revision

    The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.   The revised Annex comes after hints earlier this year that it be out in mid-2022. (RELATED: EU GMP Annex 1 revision to be released mid-year ...
  • RAPSRAPS' LatestRAPS AnnouncementsRAPS Announcements

    What it’s like to present a poster at Euro Convergence, with Raquel Carnero

    Euro Convergence, RAPS’ annual gathering of medical device, in vitro diagnostic (IVD) and pharmaceutical regulatory professionals, returned in person to Amsterdam on 11-13 May 2022 . More than 500 participants, including 120 industry expert speakers from more than 30 health authorities and notified bodies, made it an event to remember in Amsterdam after two years of virtual conferences. Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raque...
  • 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 AnnouncementsRAPSRAPS' 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...