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  • Regulatory NewsRegulatory News

    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...
  • Regulatory NewsRegulatory News

    Foreign Threats to NIH Research: Senate Finance Committee Digs In

    China, Russia and Iran were singled out in a Senate Finance Committee hearing on Wednesday as countries that are looking to either undermine or usurp scientific research conducted with US taxpayer funds. Committee Chairman Chuck Grassley (R-IA) made clear that China is “by far the most prolific offender,” offering the example of attempts by Chinese researchers to steal genetically modified corn seeds in Iowa and send them back to China. “Researchers who are secretly ...
  • Regulatory NewsRegulatory News

    HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices

    President Donald Trump's Department of Health and Human Services (HHS) Secretary nominee Alex Azar told the Senate Finance Committee on Tuesday that drug prices "are too high" and he will work to bring them down, though, "There's no silver bullet." Azar previously told the Senate Health, Education, Labor and Pensions Committee that drug prices will be his top priority. The comments on Tuesday followed questions raised by Sen. Ron Wyden (D-OR) and others regardi...
  • Regulatory NewsRegulatory News

    South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    Australian Regulator Hits Restart on Plan to Name Biosimilars

    Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy. Background Under TGA's original proposal , biosimilars would have been referred to using their Australian Biological Name (ABN) followed by the prefix “sim(a),” whe...
  • Regulatory NewsRegulatory News

    Australian Regulator TGA Undergoing Reorganization

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a " smaller and more rational " government. The D...
  • India's Health Ministry Releases New Clinical Trials Requirements

    India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics. Background India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country ...
  • Senate Investigation Claims Medtronic Edited, Influenced Studies

    • 25 October 2012
    • By
    A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of millions of dollars to experts who authored company-sponsored studies. The 2,300-page report (PDF, 150 MB) was triggered in part by a 2009 investigation conducted by Med Page Today and the Milwaukee Journal-Sentinel that found the company to have engaged in ghostwri...
  • Indian Task Force Recommends Adoption of Authentication System for Pharmaceuticals

    Taking a page out of the anti-counterfeiters' playbook, a high-level Indian task force has recommended the adoption of verification technology and mobile text messaging authentication for medicines produced and sold in India, reports BioSpectrum Asia . The technology is already in use in some African countries such as Kenya and Ghana , but the adoption scale recommended by the Union Health Ministry's task force on pharmaceutical manufacturing would dwarf those in sca...
  • Dutch Regulatory Authority Echoes Warning on Faulty Breast Implant Products

    • 19 March 2012
    • By
    The Dutch Health Ministry is warning thousands of women about the risks associated with breast implant products manufactured by French firm Poly Implant Prothese (PIP) after becoming concerned about their potential to rupture, reports Reuters . The implants were reportedly made with industrial-grade silicone and may be rupturing at an abnormally high rate. In light of the potential risks, the Dutch Health Ministry is asking women to consider having the implants removed ...
  • Indian Science & Technology Minister Calls for Transparent, Evidence-based Regulatory System

    The head of the Indian Ministry of Science and Technology, Minister Vilasrao Deshmukh, called for a new emphasis on science and technology, including regulatory science, during a speech on 3 January 2011. Speaking at the Indian Science Congress in Bhubaneswar, Odisha, India, Minister Deshmukh said that research and development (R&D) spending should double under a new science and technology policy so that India can catch up to China, according to Biospectrum Asia ...