• 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 ...
  • Feature ArticlesFeature Articles

    Foods for special medical purposes/medical foods: A global regulatory synopsis

    This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...
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    Nutrition and health claims in the European Union in 2022

    Nutrition and health claims are widely used on food labels and may positively influence consumer perceptions and intentions to buy food. Regulation (EC) 1924/2006 on nutrition and health claims aims to ensure claims are clear, scientifically substantiated, and supports consumers to make informed decisions. The European Commission (EC) is working to introduce a legislative proposal on nutrient profiles in 2022 to restrict the use of claims on foods high in saturated fat, su...
  • 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...
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    Getting ready for the FDA’s upcoming QMSR

    The FDA’s Quality Management System Regulation (QMSR) proposal, paired with the International Organization for Standardization’s ISO 13485:2016, is expected to deliver cost savings to medtech organizations that adhere to both requirements. This article covers the differences between QMSR, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP) so leaders can prepare for the upcoming changes.    Keywords – MDSAP, quality management, quality system regulat...
  • Regulatory NewsRegulatory News

    EMA reports steady rise in clinical trial applications registered in CTIS portal

    Nearly 195 clinical trial applications (CTAs) have been submitted to the European Medicine Agency’s (EMA) Clinical Trial Information System (CTIS) portal through July, marking a substantial increase from a month earlier, according to a 23 August report from the agency.   However, during the same period, most applications (224) were still being registered in the older EudraCT database. (RELATED: EMA reports slow uptick in clinical trial applications submitted via CT...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Feature ArticlesFeature Articles

    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
  • RF Quarterly

    The history of clinical trial disclosure

    The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...
  • Regulatory NewsRegulatory News

    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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    MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

    The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...
  • Regulatory NewsRegulatory News

    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...