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    On Eliminating Two-Year Rat Carcinogenicity Studies for Pharma: ICH Seeks More Data

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue to study for two more years whether guidance can be revised on certain situations when sponsors will not have to conduct and submit a two-year rat carcinogenicity study for a developing drug. In order to test the feasibility of eliminating such studies in some cases, which would be part of revisions to ICH’s S1 Guideline , ICH began collecting vol...
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    Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed

    The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety. The goal of the potential changes to the S1 guidance, according to EMA, is to introduce a better way to address the risk of human carcinogenicity o...
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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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    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
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    Amended ICH GCP Guideline Addresses Evolution of Trials Landscape

    The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials. The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to fa...
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    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
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    EMA Gives Details on New Elemental Impurity Guideline

    The European Medicines Agency (EMA) has released its recommendations for implementing a newly adopted international standard for limiting elemental impurities in drug products. Background Elemental impurities are traces of metals that can end up in finished drug products. These impurities can come from multiple points in the manufacturing process, such as residual catalysts from a product’s synthesis or from contact with manufacturing equipment, containers and other m...
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    FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality

    New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products. Background The draft guidance, Development and Submission of Near Infrared Analytical Procedures , is focused on NIR analytical procedures, which are used to identify pharmaceutical starting materials, unfinished drugs and finished pharmaceutical products. N...
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    ICH Takes Step Toward New eCTD Version

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...
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    FDA Adopts International Photosafety Testing Standard

    New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients. The standard, S10 – Photosafety Evaluation of Pharmaceuticals , was developed by the International Conference on Harmonisation (ICH), an international body composed of FDA, the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Device Agency (PMD...
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    US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences

    US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week. Background Both governments' efforts come from a 2012 regulatory initiative known as the Regulatory Cooperation Council (RCC), whose stated goal is to increase regulatory cooperation between both countries. That cooperation, ...
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    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...