The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October . Revised Guidance The revision updates the previous version released in March , which clarified the agency's expectations for the data required to submit for publishing under the agency's clinical trial transparency rules. EMA says it has updated the section on the guidance's sc...

The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex. The  revised guideline , which is open for public consultation until 28 February 2017, is intended to further assist sponsors in the transition from non-clinical to ea...

The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices. According to the agency, the guidance has been updated to reflect a standardized approach to collecting race and ethnicity data in accordance with requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Inn...

The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a new online database. "Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based," said EMA Executive Director Guido Rasi, adding that the initiative "will benef...

This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs. Introduction Earlier this year, the China Food and D...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...

The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation. The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provid...

The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in development of FDA-approved new molecular entities and new biological therapeutics. The comments, which should be submitted by 18 November , may assist FDA in developing databases on biomarkers for drug development in the future, the agency said. Background Biomarkers are frequently use...

The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...

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 ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Promises to Punish Clinical Trial Fraud, Outlines Vision for Future of Drug Regulation Chinese regulators are working with the legal system to ensure clinical trial data fraud is punished in the courts. The initiative, which is a near-term priority for officials, forms part of China’s vision for the development of its drug regulatory system between now and 2020. Chi...

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity. FDA says it received 151 comments from seven entities , including the Advanced Medical Technology Association (AdvaMed) and AstraZeneca, on the draft guidance and “incorporated most of them in this final guidance.” Guidance Adaptive trial designs , first...