RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

    China's State Food and Drug Administration (SFDA) issued new regulations on 15 August instructing provincial governments to publish on their websites so-called Black Lists of drug and device companies that engage in counterfeiting and related illegal activities.   The websites are to include the name of the company, its business address, the name of the legal representative or responsible person, and the individual's title.  Violations that would justify...
  • New Portable Anti-Counterfeiting Technology Promises 'Paradigm Shift'

    • 02 August 2012
    The US Pharmacopoeia (USP) has developed a new technology that holds the promise of detecting substandard and counterfeit medicines with greater accuracy, sensitivity and reliability than other field-based portable tools. In a statement , USP said the development of the technology, called "PharmaCheck," was done in response to a challenge from the Bill & Melinda Gates Foundation and the needs of patients in the developing world. "Substandard and counterfeit medicin...
  • Top Russian Regulator: We Don't Have Authority to Stop Counterfeiters

    • 26 July 2012
    Russia's top regulator is claiming Russian regulators are handicapped in the fight against counterfeiting because no penalties exist under Russian law to prohibit the sale and production of counterfeit drugs. In an television interview, the Acting Head of Roszdravnadzor, Elena Telnov, said her agency is powerless to stop counterfeiters, and provided an exemple of a fake cancer drug in the Rostov region of Russia where counterfeiters were located but could not b...
  • House Passes Bill Enhancing Penalties for Counterfeiters

    • 19 June 2012
    The US House of Representatives passed a bill on Monday, 18 June that would update the US' criminal code to establish harsher penalties for those found guilty of counterfeiting pharmaceutical products. The legislation, the Counterfeit Drug Penalty Enhancement Act of 2011 , is sponsored by Rep. Patrick Meehan (R-PA) and was introduced in the House in December 2011. An identically-titled companion bill first sponsored by Sen. Patrick Leahy (I-VT) is still before the S...
  • MHRA Warns of Counterfeit Medical Devices

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) sent out a warning to physicians and consumers on 15 June regarding the discovery and seizure of several counterfeit medical devices sold through online retailers. The agency said it had seized more than 400 discount-priced digital thermometers lacking proper CE safety marking, warnings or instructions for proper use. Further, the devices were discovered to be dispensing improper temperature results, and...
  • J&J Warns Physicians About Counterfeit Medical Device

    • 14 June 2012
    Life sciences manufacturer Johnson & Johnson's subsidiary Ethicon this week warned physicians about counterfeit copies of its Ligaclip Extra Ligating Clip Cartridges, which are used for tubal ligation. The company explained in a "Dear Healthcare Provider Letter" that its investigators had discovered counterfeit copies of the device in at least two countries-the US and Hong Kong-and the company was working with regulatory authorities in both countries to track the sou...
  • Hamburg Continues to Call for More Anti-Counterfeiting Authority

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters . For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain. Speaking on Wednesday, 7 June to The Financial Times , Ham...
  • Consumers Warned of Fake Adderall in US

    The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy. ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine ...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • Researchers Gauge Effects of Regulatory Systems on Counterfeit Medicines

    A new paper exploring counterfeit and substandard medicines shows the presence of even a minimally-developed regulatory program can have a profound impact on ensuring consumers have access to genuine, quality medicines. The study, " Counterfeit or Substandard? The Role of Regulation and Distribution Channel in Drug Safety ," was published as a National Bureau of Economic Research (NBER) working paper and authored by Roger Bate and Aparna Mathur of the American Enterpri...
  • MHRA Launching New Anti-Counterfeiting Strategy

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is unveiling a new Falsified Medical Products Strategy it says will improve its existing anti-counterfeiting strategy by enhancing communication, collaboration and regulatory activities between MHRA and stakeholders. The agency's updated strategy will seek to enhance its original strategy by focusing on preventing counterfeit products, changing how counterfeit products are handled once they are found...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...