• RF Quarterly

    Evolution of the Japanese regulatory system and agencies

    The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...
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    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...
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    How to prepare for the RAC exam

    Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the leading credential for regulatory professionals in the healthcare product sector. It shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but also that you are committed to your profession. To get the credential, you must pass one of two challenging RAC exams. The average pass rate is between 40% ...
  • Regulatory NewsRegulatory News

    MITA Raises Questions With Pre-Cert Software Pilot

    The Medical Imaging & Technology Alliance (MITA) this week raised questions about the value of participating in a new US Food and Drug Administration (FDA) Pre-Certification pilot for software as a medical device (SaMD) products. While noting how an increasing number of SaMD products are coming to market to be used in the diagnosis and treatment of medical conditions, MITA Executive Director Patrick Hope says the alliance supports efficient FDA oversight to allow produc...
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    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 ...
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    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....
  • Feature ArticlesFeature Articles

    Third Party Certification for Drugs Associated With an Import Alert Exception

    The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert a...
  • Regulatory NewsRegulatory News

    Professors Offer 3 Questions on FDA’s New Digital Health Framework

    The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs , who offer up three questions about the direction of the plan. First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not includ...
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    192 Earned Regulatory Affairs Certification (RAC) in Spring 2017

    Today, RAPS congratulates the 192 regulatory professionals who earned Regulatory Affairs Certification (RAC) during the recent spring 2017 exam period. The RAC credential is earned by passing one of four exams , and is the only professional credential specifically for regulatory professionals in the healthcare product sector. RAC holders must maintain their certification through continuous learning and professional development, recertifying every three years. Currentl...
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    FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

    The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    Get RAC Questions Answered at the Regulatory Convergence

    If you are planning to attend RAPS’ upcoming Regulatory Convergence in Baltimore, 24–28 October, and you are thinking about pursuing Regulatory Affairs Certification (RAC) or have questions about the RAC, you should plan to attend one of the conference’s two scheduled RAC mini-sessions. The RAC mini-sessions are 45 minutes long and will be held in between educational sessions on Monday and Tuesday. These interactive sessions will give attendees the opportunity to...