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  • Regulatory NewsRegulatory News

    Health Canada to Increase GMP Inspections, Promises Greater Transparency

    Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future. The move comes in the wake of an ongoing investigation by The Toronto Star , which has uncovered cases of data manipulation and unreported side effects at manufacturers supplying products to Canada. The paper made these revelations after obtaining inspection reports from the US Food and Drug Administration...
  • Regulatory NewsRegulatory News

    Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

    A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports. The researchers, led by Beate Wieseler, head of the department of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG), wanted to determine if the reporting requirements for early benefit assessment in Germany yielded more comp...
  • Regulatory NewsRegulatory News

    German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad

    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. German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad. In comments submitted to EMA, Beat...
  • Regulatory NewsRegulatory News

    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    EMA Seeks Feedback on Clinical Trial Database

    In 2014, the European Medicines Agency (EMA) made headlines when it announced it would require pharmaceutical companies to report the results of their clinical trials. Now, in a new notice , EMA is asking for help in determining how it should make that information available to the public, including how it should balance transparency with confidentiality.      Background In April 2014, the European Parliament overwhelmingly passed its new Clinical Trial Regulation ,...
  • Regulatory NewsRegulatory News

    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...
  • Regulatory NewsRegulatory News

    The Case for Sharing Private Drug and Device Data

    A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products. Background The report, Facilitating Medical Product Development Through Voluntary Data Sharing , makes the argument that "wide sharing of research data would be good for scientific discovery and the enterprise of medical product development as well...
  • Regulatory NewsRegulatory News

    In Landmark Decision, EMA Adopts Clinical Trials Transparency Plan

    In a landmark decision with wide-ranging implications for drugmakers around the globe, the European Medicines Agency (EMA) has announced it will soon require pharmaceutical companies whose products are approved for sale in the European Union to make all clinical data supporting the approval of their medicines freely available to the public. Background As Focus explained earlier this year , EMA has for years been seeking a policy by which it could release patient-anon...
  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Regulatory NewsRegulatory News

    FDA Grapples With Lesser-Known Costs of Clinical Trials Transparency

    US medical device regulators soon plan to hold a public hearing to discuss how the results of cardiovascular outcomes trials (CVOTs) can be kept confidential until they are completed. Background The meeting, previewed by the US Food and Drug Administration (FDA) in a 14 July 2014 Federal Register notice, comes after years of the agency placing more of an emphasis on mandatory post-market approval trials. Those trials are meant to assuage outstanding regulatory concer...
  • Regulatory NewsRegulatory News

    EMA Prepares to Free up Clinical Trials Results Starting Next Month

    In less than a month, pharmaceutical companies operating in the EU will need to begin posting clinical trial results in the European Clinical Trials Database (EudraCT) under a new plan meant to expand the amount of information available to consumers. Background The plan was first announced by the European Medicines Agency (EMA) in October 2013, when it said that an update to EudraCT, dubbed EudraCT V9, would enable pharmaceutical companies to post new types of...
  • Regulatory NewsRegulatory News

    EMA Adopts Changes to Trials Transparency Policy, October 2014 Start Date Predicted

    The European Medicines Agency's (EMA) management board has signed off on the regulator's clinical trials transparency policy, adopting several changes along the way the regulator said would make the data the policy is intended to provide access to "more user-friendly." Background As Focus explained earlier this week , EMA has for years been seeking a policy by which it could release patient-anonymized clinical trials data used to support drug approvals to the p...