• Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer. In the previous product informa...
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    Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant

    European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP. “The concerned API-batches or finished product containing the API should not be imported to the EEA [European Economic Area],” the agency said. “All API batches manufactured during the year 2014 are conce...
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    Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer

    The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues. AIFA says that based on its inspection from 8 October, Iason does not comply with good manufacturing practice (GMP) requirements. This is the third GMP non-compliance report posted to one part of EudraGMDP – the European database of pharmaceutical manufacturing violations -- in rece...
  • Feature ArticlesFeature Articles

    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...
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    Japan Launches NIH Analogue

    Today marks the launch of Japan’s new Agency for Medical Research and Development (AMED), which will take on the role of leading research and development in the country through partnerships between universities and industry. The agency’s launch is part of a larger restructuring of Japan’s publicly funded research and development sector. Background AMED was created following the passage of two acts in 2014, The Act on Promotion of Healthcare Policy and the Act on t...
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    Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

    In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks. Background In November 2013, FDA  proposed a rule to allow  generic drug manufacturers to temporarily update their labels if they were made aware of n...
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    FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More

    The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA) . Background The posting of the BAA is an annual tradition for FDA. The announcement outlines the research and development topics the agency hopes ...
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    Canada Launches Ebola Vaccine Trial

    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. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
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    DOD Steps Onto FDA Turf, Seeking to Evaluate Safety and Effectiveness of LDTs

    The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...
  • Regulatory NewsRegulatory News

    FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics

    The US Food and Drug Administration (FDA) has released its latest " Broad Agency Announcement " detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs. Like FDA's 2013 Broad Agency Announcement, the 2014 announcement says FDA is prepared to spend—"subject to congressional appropriations"—as much as $50 million on meeting nine overarching goals and dozens of sub-level interests. ...
  • Skerritt Takes Reins as New Head of TGA

    Australia's Therapeutic Goods Administration (TGA) announced on 1 June the confirmation of Dr. John Skerritt as the new National Manager of the agency, ending a month-long lead-up process. Skerritt replaces Dr. Rohan Hammett, who resigned from the agency in December 2011 , and comes to the agency in the midst of a tremendous reorganization to combine the regulatory authorities of Australia and New Zealand into a single trans-national regulatory authority known as the ...
  • TGA Announces New Head of Agency

    Australia's Therapeutic Goods Administration (TGA) announced it has appointed Dr. John Skerritt, previously the Deputy Secretary of the Department of Primary Industries in the Victorian government, as the new national manager of TGA. In a statement posted on the agency's website on 2 May, TGA said Skerritt will take control of the agency at the end of May 2012 and said Skerritt is highly qualified to run the agency well. "Skerritt currently leads more than 1200 staff (i...