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  • Regulatory NewsRegulatory News

    France Begins Speeding Clinical Trial Start-Up Times

    As part of a push to more quickly offer patients access to innovative treatments, France’s drug regulator, known as ANSM, has established two “Fast Track” options that will expedite the authorization of clinical trials. Unlike the US Food and Drug Administration’s (FDA) Fast Track process, which is designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, France’s new designation concerns clinical trials of innovative treatment...
  • Feature ArticlesFeature Articles

    France Reimbursement Profile

    This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process. Introduction Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies, such as Haute Autorité de la Santé (HAS), is...
  • Regulatory NewsRegulatory News

    FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors

    The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors. Working alongside the European Medicines Agency (EMA) and ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    French Regulator and Roche Trade Blows Over Off-Label Avastin Use

    On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015. Background Health authorities around the world have been eyeing Avastin (bevacizumab) as a cheaper alternative to Novartis' Lucentis (ranibizumab injection). After being app...
  • After US Compounding Fiasco, France Confronts Similar Safety Crisis

    • 24 January 2014
    In the US, a massive and deadly outbreak of fungal meningitis in 2012 prompted regulators to take a close look at compounding pharmacies, ultimately finding that many made products using procedures that did not meet federal standards for good manufacturing practices. Now France may be on the cusp of starting some regulatory soul-searching of its own after the deaths of four newborns were linked to parenteral nutrition bags made by a small manufacturing laboratory, Pharma...
  • French Regulators Issue Warning About Celgene's Abraxane

    • 23 January 2014
    French regulators on Wednesday issued a warning regarding Celgene's pancreatic cancer drug Abraxane (paclitaxel), saying that "fine protein filaments" had been observed in some drug units. The warning, issued by the French regulatory authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), said that the 1-2 mm-long white and yellow filaments had been observed during visual inspections of the drug, but were not thou...
  • Safety Concerns Assuaged, Birth Control Pill Back on the Market in France

    • 14 January 2014
    An acne drug also commonly used for birth control indications is slated to return to the market in France more than a year after French regulators first warned that the drug could be dangerous, prompting an EU-wide review of the drug and changes to its approved indications. Background The drug, known as Diane 35 (cyproterone acetage 2mg, ethinylestradiol 35µg), had been associated with an elevated risk of developing venous and arterial thromboembolisms (VTE/ATE), ...