• Regulatory NewsRegulatory News

    Brazilian Regulator Anvisa Issues New Track and Trace Guidance

    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. Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM).  The guidance manual , released 18 August 2014, specifies the requirements for mandator...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • Anvisa Approves Track and Trace System

    The board of Brazil's National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale. Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a...
  • Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature

    The Senate, after a series of long delays , has finally passed the Drug Quality and Security Act (DQSA) , all but assuring the law's provisions to institute a national track and trace system and new compounding regulations will be signed into law later this month. Background The  DQSA  was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While Californi...
  • New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

    US legislators have announced that they have overcome differences in their approaches to reforming the regulation of compounding pharmacies and the pharmaceutical supply chain, clearing a path for potential approval. Background As regular readers of Regulatory Focus know, legislation to reform pharmaceutical compounding and track and trace has been in the works for months. In general, the House of Representatives and Senate have taken different approaches toward refo...
  • As US Congress Returns to Washington, Senator Calls for Work to Resume on Track and Trace Measures

    • 12 September 2013
    With the mercury set to fall in the US capital of Washington, DC, after a relatively uneventful few months, the stage is slowly being set for a number of legislative issues pertinent to the regulation of healthcare products to return to the congressional spotlight. But while much attention is likely to be paid to pharmaceutical compounding, at least one senator is trying to make sure the safety of the pharmaceutical supply chain doesn't get placed on the backburner for a...
  • Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has released an updated version of legislation meant to enact a track and trace system for pharmaceuticals, as well as new regulations to crack down on deficient pharmaceutical compounding practices that resulted in a massive outbreak of fungal meningitis in late 2012. Background Both the Senate and House of Representatives have been working independently of one another to push forward measures on bo...
  • Feature ArticlesFeature Articles

    Global Tracking Regulations Present Challenges and Benefits

    • 16 July 2013
    Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization. The foundation of any tracking system is serialization, which entails affixing to finished drugs a unique serial num...
  • FDA Fast Tracks Fecal Transplant Product Intended to Treat Clostridium Difficile Infections

    Last week, the US Food and Drug Administration (FDA) quietly announced it would be backing off a previous proposal to require fecal microbiota transplants to be conducted under either an approved biologics license application (BLA) or investigational new drug (IND) application. Now, however, it has announced the approval of fast track designation for an investigational product sponsored by Minnesota-based Rebiotix, potentially one of the first - if not the first - product...
  • Track and Trace Passes House of Representatives with Major Support, Now Moves to Senate

    US legislators in the House of Representatives passed a major piece of legislation on Monday afternoon, passing by a voice vote a measure meant to secure the pharmaceutical supply chain from counterfeit products. Track and Trace The first bill is known as the Safeguarding America's Pharmaceuticals Act (SAPA) , and institutes a system more commonly known as "track and trace," so-called because it allows authorities to track where a product is going and trace where i...
  • Costs of Proposed Pharmaceutical Track and Trace System Come into Focus for FDA, Industry

    House legislators have for months been pushing through a piece of legislation that would overhaul the security of the pharmaceutical supply chain, putting into place a series of provisions known more generally as "track and trace." And after being made aware of the legislation's language, the pharmaceutical industry and US Food and Drug Administration (FDA) are now getting a glimpse of something else: Its cost. Pharmaceutical Industry: Cost Drivers In an estimate releas...
  • Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA) regulates the compounding, tracking and tracing of pharmaceutical products. Pharmaceutical Compounding Both the House and Senate are concurrently working on two sets of proposals: one to change how pharmaceutical compounders are regulated, and one to shore up the pharma...