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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
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    EMA Offers Guidance on Post-Brexit Changes as Industry Groups Call for Transition Period

    The European Medicines Agency (EMA) on Tuesday outlined the requirements that companies should follow when they apply for changes to their marketing authorization to allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU. The guidance, which comes in the form of nine questions and answers and anticipates that the UK will leave the EU as of 30 March 2019, was released on the same day that EU pharma...
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    European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Trade Groups Propose Criteria for Deciding New Home of EMA European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission...
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    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
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    European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Complaints About Delayed Clinical Trial Starts Prompt EMA to Consider Revising Guidance The European Medicines Agency (EMA) is considering revising its guidance on clinical trial reference safety information (RSI) after drug developers complained the current situation is delaying the start of studies. In response to the grievances, EMA has encouraged the industry to discuss ...
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    ICH Makes Organizational Changes

    The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law. ICH says its changes will help it to expand its membership, which currently includes pharmaceutical regulators from the US, EU, Japan, Canada and Switzerland. "More involvement from regulators around the world is welcomed and expected … This is matched by the possibility of wider inclusion of glob...
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    EU Personal Data Protection Reforms Move Forward

    After three years of deliberation, the European Council has agreed on its approach to data protection reform, allowing the council to initiate a trilogue with the European Parliament and Commission. Background The current rules governing data protection in the EU were adopted in 1995 under Directive 95/46/EC . However, there have been massive changes in how data is generated and used in the 20 years since the directive was adopted. In 1995, few Europeans had Internet...
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    European Industry Group Calls for Drug Shortage Reporting Standards

    A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication. In its report, the group recommends a set of harmonized standards for how drug shortages caused by quality or manufacturing issues are communicated to relevant authorities. Background Currently, marketing authorization ...
  • Pfizer Announces Adoption of Trials Transparency Policy, Illustrating Industry-Led Effort

    • 05 December 2013
    In a major but expected change, pharmaceutical manufacturing giant Pfizer has announced that it will expand the ability of outside researchers and patients enrolled in its clinical trials to access results and other clinical data. Background Transparency advocates have for years been pushing for greater access to the data, saying outside researchers should be permitted to validate study results and dig into data to find unreported safety or efficacy issues. And for year...
  • As EMA Inches Toward Clinical Transparency, EFPIA Calls for Agency to Watch its Word Choices

    When it comes to legislation and regulation, word choice matters greatly. As any lawyer who specializes in constitutional law can tell you, the inclusion of a single seemingly inconsequential word can mean the difference between a policy that stands the test of time and one that is subject to endless argument. And when it comes to a new draft policy proposed by the European Medicines Agency (EMA) that would increase clinical trials transparency in the EU, the inclusion o...
  • PhRMA, EFPIA Call for Clinical Data Transparency, but Principles Fall Short of EMA Proposal

    In an abrupt about-face, two of the most prominent pharmaceutical industry associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have announced a new set of "joint principles" meant to advance clinical data transparency throughout the pharmaceutical industry. Background In recent years, a growing number of voices have been clamoring for greater transparency of cli...
  • Industry Pledges Tentative Support for Clinical Trials Data Transparency

    • 14 November 2012
    Greater transparency of clinical trials data has long been the goal of many academic researchers, who claim withheld data can often mask troubling safety issues. Now, those researchers are being joined by an unlikely ally: industry. Manufacturing giant GlaxoSmithKline made headlines in October 2012 when it announced it would shift to a new transparency model in which it would allow select researchers to access trials data. "Detailed clinical trial data to enable addit...