• Feature ArticlesFeature Articles

    October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

    Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.   Linguistic review and herbal product regulation The linguistic review process for centrally authori...
  • Feature ArticlesFeature Articles

    The regulatory landscape of advanced therapies in Asia-Pacific

    The Asia-Pacific region, which inlcudes Australia, China, Hong Kong, Japan, Malaysia, Singapore, and South Korea, has a significant number of clinical trials in advanced therapies, with China ranking second globally. Manufacturers in other countries in the region, such as Japan, Australia, South Korea, and Singapore, have submitted marketing authorizations applications for advanced therapies and received approvals. Regulators recognize this emerging trend in dynamic resear...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • Feature ArticlesFeature Articles

    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...
  • RoundupsRoundups

    Asia-Pacific Roundup: Singapore seeks feedback on planned unique device identification system

    Singapore’s Health Sciences Authority (HSA) is seeking feedback on the regulatory requirements for the planned implementation of a unique device identification (UDI) system. HSA wants to establish a harmonized identification system to enable the traceability of medical devices.   Today, HSA lacks the means to track the distribution and use of medical devices across the supply chain and healthcare system. HSA wants to gain that power to support the timely identification...
  • RoundupsRoundups

    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
  • Regulatory NewsRegulatory News

    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Professional and career development

    Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on dissemin...
  • Feature ArticlesFeature Articles

    Evolution of the regulatory intelligence profession

    Regulatory intelligence has gained significant importance with increasingly global considerations for product development, clinical trials, and submissions to ensure market access in key regions. The regulatory intelligence profession, tasked with providing strategic input to ensure regulatory compliance, has evolved to fulfill the additional needs of various departments within the company and by senior leadership by strategically analyzing relevant regulations and product...
  • Feature ArticlesFeature Articles

    The regulatory profession by the numbers: RAPS’ 2020 compensation and scope of practice survey

    The RAPS 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession presents an analysis of nearly 2,000 responses from regulatory professionals from around the world who participated in an online survey in April 2020. The following article reviews the main findings from the 2020 report, focusing on regulatory professionals’ levels of education and certification, experience, the most common regulatory functions performed, and career and job motivatio...