• Regulatory NewsRegulatory News

    WHO Adopts Weakened Resolution on Drug Price Transparency

    The World Health Organization (WHO) on Tuesday adopted a resolution to urge countries to publicly share the net prices of health products and the costs of clinical trials. The resolution, adopted after three weeks of negotiations, also calls on United Nations member countries to better facilitate the public reporting of patent status information and marketing approval status of health products, as well as to improve national capacities for open and collaborative researc...
  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
  • Regulatory NewsRegulatory News

    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    235 Earn Regulatory Affairs Certification (RAC)

    A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios. By passing, each of the 235 professionals now hold ...
  • Regulatory NewsRegulatory News

    EMA Consults on Regulatory Science Strategy to 2025

    The European Medicines Agency (EMA) on Wednesday launched a six-month public consultation on its proposed strategy for regulatory science through 2025 following two recent multi-stakeholder workshops on the topic.   “The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said EMA Executive Director Guido Rasi, adding that the agency developed the plan with input from t...
  • Regulatory NewsRegulatory News

    Woodcock Pushes for Major Digital Shift in Regulation

    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world. “The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday. She noted that regulators arou...
  • Regulatory NewsRegulatory News

    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA Scales Back Medium-Priority Activities as Brexit Bites

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Scales Back Medium-Priority Activities as Brexit Bites   The European Medicines Agency (EMA) has scaled back certain medium-priority activities to offset the effect of Brexit on its capacity. EMA is further pulling back from international collaborations and suspending certain types of meeting until at least 30 June.   EMA triggered the changes by initiating ...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: MHRA Extends EpiPen Expiry Dates to Mitigate Supply Shortages

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   MHRA Extends EpiPen Expiry Dates to Mitigate Supply Shortages   MHRA has allowed Mylan to extend the expiry dates on certain lots of EpiPen to mitigate supply constraints. The organizations think delaying the expiry of nine lots of the adrenaline auto‐injectors by four months will help ensure patients can access the products while Mylan stabilizes supply.   The ...
  • RAPS' LatestRAPS' Latest

    RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

    RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global. The RAC is the only post-academic professional credential for the healthcare product regulatory field....
  • RAPS' LatestRAPS' Latest

    8 Networking Tips for Regulatory Convergence Attendees

    The 2018 RAPS Regulatory Convergence at the Vancouver Convention Centre in Vancouver, BC, 1–4 October, will offer attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. At the Convergence, you will be surrounded by people who truly ‘get it.’ They understand regulatory issues, and have gathered together to examine them in depth, share ideas and meet other like-minded pr...
  • RAPS' LatestRAPS' Latest

    10 Ways to Get the Most From RAPS' Regulatory Convergence

    Your time is valuable. We respect and appreciate the time you take to attend the  Regulatory Convergence , and we want you to get as much out of RAPS’ signature annual event as you can. After all, it is an investment in your job, your career and your regulatory knowledge. And for those of you who may be first-time attendees, it can be particularly helpful to have an idea of what to expect. So we have a few tips to help you make the most of your Convergence experience this...