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  • Regulatory NewsRegulatory News

    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
  • Regulatory NewsRegulatory News

    EU Pediatric Regulation’s 10-Year Anniversary Report Highlights Shortcomings

    Ten years ago, the European Commission created a new regulation as part of an effort to try to encourage more pediatric research. But in the years since, companies have been slow to increase their development of treatments for pediatric populations, particularly in oncology, where many of the medicines used were developed in the 1990s, “if they exist at all,” an EC report released Thursday said. The report highlighted that the number of completed pediatric investig...
  • Regulatory NewsRegulatory News

    EU Court of Justice Clarifies Product Liability for Notified Bodies

    The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives. But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable....
  • Regulatory NewsRegulatory News

    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
  • Regulatory NewsRegulatory News

    EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer. The review of using primates for biomedical research comes as...
  • Regulatory NewsRegulatory News

    MHRA Suspends All Devices from Largest South American Silicone Implant Manufacturer

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA), alongside EU member state regulators, announced Wednesday the suspension of all CE certificates for medical devices made by Brazilian manufacturer Silimed. The suspension comes as a German notified body recently inspected one of the Brazilian manufacturing sites of Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, and ...
  • Regulatory NewsRegulatory News

    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
  • Regulatory NewsRegulatory News

    EMA Hopes Early Dialogue With Drugmakers Will Spur Pediatric Drug Development

    The European Medicines Agency (EMA) is piloting a new initiative to offer early meetings with companies to foster discussions about their pediatric development strategies for new medicines. Background Companies are often reluctant to conduct clinical studies in children due to ethical concerns and fear of adverse events during trials. However, conducting clinical research on children is critical to determining whether drugs are safe and effective in pediatric population...
  • Regulatory NewsRegulatory News

    Are Notified Bodies Responsible for the Failure of Companies They Oversee?

    A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports. Background For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut ...
  • Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison

    • 10 December 2013
    The former CEO of a now-disgraced manufacturer of breast implants that was accused of willfully misleading regulatory officials for years has been found guilty by a French court and sentenced to four years in Jail. Background Jean-Claude Mas, former CEO of the now-defunct manufacturer Poly Implant Prothese (PIP), was accused in 2010 of distributing hundreds of thousands of breast implant products made with deficient, industrial-grade silicone without the approval of reg...
  • European Commission Committee Clears PIP Breast Implants of Major Health Concerns

    The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...
  • European Commission Releases First Report on the Pediatric Regulation

    The European Commission today published a progress report on medicines for children covering the five years since the Pediatric Regulation came into force. Although it will take several more years to fully assess the impact of the legislation due to long drug development cycles, this preliminary review points to significant improvements in the pediatric medicines landscape: better and safer research, more products for children on the EU market and more information for p...