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    Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database

    Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information. The database, known as Global Ingredient Archival System (ginas), provides a common identifier for all APIs and provides a consistent definition of substances globally, consistent with the ISO 11238 standard . The effort, which its developers describe as similar ...
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    UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

    UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe. In February, ANSM inspected Anuh Pharma’s Maharashtra-based site and uncovered 24 deficiencies, including one that was critical and two that were major. The critical deficiency was linked to the fact...
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    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
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    Chinese Heparin Sourcing Questions Resurface After ANSM Inspection

    France's National Agency for Medicines and Health Products Safety (ANSM) raised two critical deficiencies over a Chinese pharmaceutical company’s manufacture of heparin, which harkens back to the scandal from 2007 and 2008 when heparin sourced from Chinese manufacturers killed 149 Americans. Following the December inspection of Dongying Tiandong Pharmaceutical Co.’s Dongying City-based manufacturing site, the site has been issued a statement of non-compliance and cannot ...
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    Updated: European Commission: Cranberry-Derived Products are not Medical Devices

    Updated with comment from Medical Brands' CEO. The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices. The need for the European Commission to make this decision on cranberry-derived products came as some companies  -...
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    Phase I Death in France: An Update on ANSM’s Investigations

    New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others. ANSM said Thursday that it “is pursuing its investigations in an aim to identify the factors which led to the dramatic accident which occurred 3 weeks ago .” The agency said this work is meant to supplement other investigation...
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    FDA Conferring With EU Counterparts on Trial Fiasco in France

    The U.S. Food and Drug Administration (FDA) announced Friday that it is conferring with European regulators, including the European Medicines Agency (EMA) and France's ANSM, after a Phase I trial resulted this week in the death of one enrolled subject and neurological injury to four others. FDA says no trials have occurred in the US with Bial’s BIA 10-2474, an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. That ...
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    EMA Will Assess ANSM Review of Botched Clinical Trial in France

    EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others. “The French authorities have opened an investigation including verification that the clinical trial has been carried out according to standards,” European Medicines Agency (EMA) spokeswoman Rebecca Harding told Focus . “EU a...
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    France’s ANSM Investigating Trial Halted After Five Patients Hospitalized, One Brain-Dead

    France’s National Agency for Medicines and Health Products Safety (ANSM) is currently investigating a Phase I clinical trial that’s been halted after the investigational drug caused brain damage in one healthy volunteer and hospitalized five others. The trial, conducted in the northwestern city of Rennes, France, was run by the contract research organization Biotrial with a total of 90 volunteers for the sponsor Bial, a Portuguese company. The investigational drug involv...
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    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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    French Regulators Suspend Catalent Manufacturing Site

    France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday. The suspension of the site, which the company says it’s unable to predict the duration of, came because of “out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior...
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    French Regulators Find Cargill Manufacturing Site Non-Compliant With GMPs

    France’s National Agency for Medicines and Health Products Safety (ANSM) has uncovered deficiencies at Cargill’s manufacturing site in Lannilis, France that have resulted in a major recall. The release of the July inspection report on 30 October detailing Cargill's violations follows a s previous decision issued by ANSM on 25 September to suspend the manufacturing, packaging, licensing, distribution, exportation and the use of active ingredients and excipients manufactur...