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  • Regulatory NewsRegulatory News

    ICMRA releases framework for aligning global track and trace systems

    The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a broad set of recommendations outlining how regulators and industry can set up track and trace systems that are globally aligned to ensure counterfeit or falsified products do not infiltrate supply chains.   The report , which was issued by a joint regulators/industry working group, explores the technical features that would allow for interoperable national and regional track and trace...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (9 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Starts Risk-Based Inspections of Online Pharmacies After Finding bad Actors The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after urgent inspections of two digital providers of primary care and a review of 43 other services rais...
  • Regulatory NewsRegulatory News

    FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores

    The US Food and Drug Administration (FDA) and other international regulators and law enforcement on Thursday announced the results of a series of actions to combat illegal and counterfeit medicines. For its part, FDA says it requested the closure of 4,402 websites that illegally marketed or sold drugs or other chemical products to US consumers, and issued 53 warning letters to website operators "for offering unapproved and misbranded prescription drug products." FDA's a...
  • Feature ArticlesFeature Articles

    Combating Counterfeit Medicines: Legal Frameworks and Emerging Technologies

    This article discusses the global problem of drug counterfeiting, reviews legal and manufacturing requirements imposed in the EU and US to protect against it and devices aimed at detecting counterfeit drugs. Introduction According to the EMA, counterfeit medicines are any medicinal product that does not comply with intellectual property rights and or infringes on trademark law 1 which differs slightly from the term falsified medicine which is described by the falsifi...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • Regulatory NewsRegulatory News

    Poor-Quality Medicines a 'Global Pandemic,' New Research Says

    Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene . Background: Counterfeit Drugs Not all poor-quality medicines are created equal. The authors of one of the articles break poor-quality medicines into three categories: falsified (including counterfeit), substandard and degraded. While each of these ca...
  • Regulatory NewsRegulatory News

    Drug Counterfeiters Could Get Life in Prison Under New Bill

    New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs. Counterfeit Bill Proposed The proposed legislation, The Counterfeit Drug Enforcement Act of 2014 , was introduced on 11 December 2014 by Rep. Steve Is...
  • Regulatory NewsRegulatory News

    New Logo to Help EU Regulators Crack Down on Online Peddlers of Fake Medicines

    EU regulators have unveiled a new scheme they say will help European consumers avoid counterfeit or falsified medicines. The scheme involves the use of a logo, which will appear on the websites of all authorized online pharmacies known to provide authentic medicines. But beyond just a logo—which authorities implied could be easily faked—the logos will then be linked to the website of each national regulator, which will maintain a list of all legally operating online ph...
  • APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing

    An international organization which counts most of Asia as members says it and its members will be committing to a joint, multi-year initiative intended to improve medical product manufacturing and the security of the medical product supply chain. In an announcement on 12 May 2014, the Asia-Pacific Economic Cooperation (APEC) group said its membership had committed to a "greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods"-a c...
  • How a New Anonymous Network May Complicate FDA's Effort to Stop Counterfeit Drugs

    Counterfeit pharmaceutical products are among the most ominous challenges global regulators, including the US Food and Drug Administration (FDA), face on a day-to-day basis. FDA routinely goes after counterfeiters, working to dismantle their operations by seizing their web properties. For example, it has regularly worked with other regulators and law enforcement officials as part of Operation PANGEA, a massive operation which has taken down thousands of websites since ...
  • EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

    EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting patients at risk. Background High-cost cancer medications like Herceptin have become an increasingly tempting target for thieves and counterfeiters in recent years. While they lack the ready market that some drugs like Viagra have, their extraordinary cost means extraordin...