• Regulatory NewsRegulatory News

    EMA wants participants to serve on clinical trial multistakeholder forum

    The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to participate in a new multistakeholder platform (MSP) or forum to share and implement ideas for improving clinical trials in the EU.   The call for participation is being launched under last year’s EC-HMA-EMA initiative Accelerating Clinical Tri...
  • Regulatory NewsRegulatory News

    Experts offer CTIS advice on eve of transition for new applications

    Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS) portal. Companies are either waiting for their colleagues to submit first or are waiting for last-minute technical glitches to be ironed out first, said an expert who recently spoke to Regulatory Focus on CTIS implementation.   Other experts told Focus that while the requirement to submit all new trials to CT...
  • Feature ArticlesFeature Articles

    Regulatory ad promo in a co-promotion setting

    Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...
  • RF Quarterly

    AI in regulatory intelligence knowledge management: A primer

    In this article, the authors discuss how recent advances in AI can be applied to support and augment various regulatory intelligence functions, including knowledge management and precedent research.   Keywords – AI, computer vision, natural language processing, regulatory intelligence   Introduction Regulatory intelligence (RI) involves analyzing large amounts of regulatory information. Much of this research is done manually and requires repetitive and ti...
  • 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...