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  • Regulatory NewsRegulatory News

    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold

    In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements.   For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a p...
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    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
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    EMA management board backs rolling review fees, COVID-19 transparency measures

    After its June meeting on Thursday, the European Medicines Agency’s (EMA) management board said it has approved a new fee for rolling reviews and that the agency will be providing more details about its approach to publishing clinical data for vaccines and drugs for coronavirus disease (COVID-19).   The new rolling review fee “would be deducted from the fee that would become due with the submission of an actual marketing authorisation application.” The specific fee a...
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    Marks dishes on COVID-19 vaccine development at BIO

    Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) told a panel at BIO Digital he thinks global regulators will be aligned on the clinical endpoints and design features of Phase 2 and 3 clinical trials for vaccines to prevent coronavirus disease (COVID-19).   Marks also emphasized that FDA is working closely with its colleagues around the world to expedite the development and availability of safe and...
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    European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the Brexit process to keep the UK in the CE-marking regime and for its national regulatory agency to formally take part in...
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    CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency

    The US Department of Health and Human Services’ Office of Inspector General (OIG) warns that "systemic issues" with the Centers for Disease Control and Prevention’s (CDC) stockpile of vaccines, antibiotics, antidotes, antitoxins, medications and other supplies could place at risk approximately $7 billion of inventory and negatively affect readiness during a national emergency. Background Created in 1999, the stockpile is meant to supplement and resupply state and...
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    WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

    The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program. The new fees will also include the setting (and public disclosure) of quantitative performance targets. Indicators and performance targets will relate to review time for full assessment, review time for abbreviate...
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    Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Caps Prices of Drug-Eluting and Bare-Metal Stents The Indian government has decided to cap the prices of drug-eluting and bare-metal stents. Officials reached the decision, which follows years of debate about the subject, after a subcommittee of cardiologists recommended that coronary stents be categorized as essential medical devices.  Members of the subcommittee ...
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    Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries

    Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program. Background Article 58 of Regulation (EC) No 726/2004, introduced first in 2004, allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with ...
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    Asia Regulatory Roundup: CFDA Looks to Overhaul Supply Chain Controls Amid Vaccine Scandal (19 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Outlines Supply Chain Overhaul Following Vaccine Scandal The China Food and Drug Administration (CFDA) has outlined plans to overhaul regulation of the supply chain in the wake of a vaccine scandal currently engulfing the country. Officials are looking to implement a full vaccine traceability system, strengthen oversight of the cold chain and reform the centralized pr...
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    Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Introduces Revised Guidance on Clinical Trials of Medical Devices China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of da...
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    Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (22 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls for Investigation Into Sellers of $88M Worth of Improperly Refrigerated Vaccines The China Food and Drug Administration (CFDA) is pressuring local government officials to probe the sale of RMB 570 million ($88 million) worth of improperly refrigerated vaccines. Police officials think the substandard vaccine ring, which was allegedly run by a mother and daughter t...