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  • Regulatory NewsRegulatory News

    Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development

    A bill introduced last year in the US House of Representatives that would reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers could end up costing public and private payers $4.5 billion over 10 years, Harvard Medical School researchers said in an article published Sunday. The economic impact of the bill, which was introduced by Rep. John Shimkus (R-IL), who is not seeking re-election, and co-sponsored by two Democrats, was ...
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    UK Details Plans to Tackle Antimicrobial Resistance Over the Next 20 Years

    The UK's Department of Health and Social Care on Thursday released two policy papers detailing the actions the government plans to address antimicrobial resistance (AMR) over the next five years and a global vision for containing AMR by 2040.   Speaking at the World Economic Forum in Davos Switzerland on Thursday, UK Health Secretary Matt Hancock called AMR "as big a danger to humanity as climate change or warfare," and called for an "urgent global response."   Whi...
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    WHO Finds Wide Disparities in Antibiotic Use Between Countries

    A new report from the World Health Organization (WHO) published Monday reveals major differences in the amount of antibiotics consumed by countries around the world and calls for changes in how countries monitor and use antimicrobial drugs.   “Overuse and misuse of antibiotics are the leading causes of antimicrobial resistance. Without effective antibiotics and other antimicrobials, we will lose our ability to treat common infections like pneumonia,” said Suzanne Hill,...
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    FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics. The meeting, part of an ongoing effort by the three agencies to spur antibiotic development in light of growing concerns about antimicrobial resistance, was the third between the three ...
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    European Regulatory Roundup: UK Prime Minister Hints at Desire to Remain Part of EMA During Brexit Transition (26 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Prime Minister May Hints at Desire for UK to Remain Part of EMA During Brexit Transition Period Prime Minister Theresa May has implied the UK will stay in the European regulatory network during the anticipated Brexit transition period. Delaying the date on which the UK cuts its ties to the European Medicines Agency (EMA) would give businesses and regulators more time to...
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    Patients Not Always Informed of Study's Purpose in Noninferiority Trials

    A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms. Unlike superiority trials, which test whether a new drug has greater efficacy than an existing therapy, noninferiority studies test that the new treatment does not fall outside a predetermined range of "clinically acceptable" inferi...
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    European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Urges Commission to Exclude Healthcare From Regulation of Professions A public health committee has urged the European Commission to exclude healthcare jobs from changes to the regulation of professions. The Committee on the Environment, Public Health and Food Safety (ENVI) is worried the proposed legislation is “too complex to implement” and involves “too much re...
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    FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

    For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence. Antimicrobial resistance has been recognized as a public health threat. The World Health Organization said it is "so serious that it threatens the achiev...
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    European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Quality of Inhaled Pharmaceutical Products The European Medicines Agency (EMA) has started a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. EMA published the concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its cu...
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    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
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    European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Plans Significant Increase in Regulatory Oversight of Antibiotics The United Kingdom government expects regulatory oversight of veterinary antibiotics to increase significantly in the future. Ministers singled out the enactment of legislation that restricts or bans the veterinary use of antibiotics that are of critical importance to people as one of the ...
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    EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

    A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators. Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how ...