• France: HAS Posts Overview of HTA Public Consultations

    France's Haute Autorité de Santé (HAS) has posted an  overview of public consultations  undertaken by the agency over the last few years, as well as an international survey of similar agencies in other countries such as the UK's National Institute for Health and Clinical Excellence (NICE). The document release is a first step in the preparation of a methodological guide for public participation in the development of health technology assessments. ...
  • France Issues New Advertising Guidelines

    • 04 June 2012
    France's recently-formed National Security Agency of Medicines and Health Products (ANSM) has announced the launch of new advertising guidelines, which it says will transition the agency from a passive verification system to a system in which advertising must be approved before publication. In its 31 May explanation of the "new methods of control" for advertising, ANSM notes requests for prior authorization must be sent to the agency per Article L.5122-9 of the Code of P...
  • New French Regulatory Agency Announces Transition of Leadership

    • 03 May 2012
    France's newly-formed National Agency for the Safety of Medicines and Health Products (MSNA), which will ostensibly replace Afssaps, announced 5 May that it will retain its existing leader, Dominique Maraninchi, for the new agency. Maraninchi will lead the new agency, established 1 May by decree, after only having been at Afssaps since February 2011. The agency has been under fire for a number of scandals, including the revelations that the agency allowed Servier's diab...
  • France: New Agency to Soon Replace AFSSAPS

    France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps. The move was announced 29 April in France's Official Journal, which noted the new agency remains under development and the change will be effective in a few months. MSNA will have a broader regulatory authority for monitoring and evaluation of health products, such as the development of independent rese...
  • Feature ArticlesFeature Articles

    The French Act N°2011-2012: Boosting Safety or Creating a Storm?

    The scandal surrounding French adjuvant therapy in hypertriglyceridemia and overweight diabetics drug Médiator, and the many deaths apparently linked to the product directly led to enactment of  The French Act N°2011-2012   of 29 December 2011 by the National Assembly. The law, sponsored by France's Ministry of Labor, Employment and Health to restore public confidence and enhance the safety of medicinal and health products, affects all stakeholders ...
  • EC Investigation of PIP Implants Inconclusive, Calls for Further Study

    A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP's breast implant products. The study, released 2 February 2012, calls for additional investigation, surveillance of the products and stress tests on the products. The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) conducted the stud...
  • Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

    • 03 February 2012
    The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier's anti-diabetes drug Mediator, according to Reuters . Mediator has been blamed for over 500 deaths in France, and was on the market for more than 30 years. After its introduction to the market in 1976, it was prescribed to nearly 5 million French citizens before it was recalled from the market in late 200...
  • PIP Executive Arrested in France, Could be Charged With Manslaughter

    • 26 January 2012
    Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a burgeoning scandal involving the manufacture and sale of allegedly substandard breast implant products. The executives, former chief executive officer Jean-Claude Mas and former chief financial officer Claude Couty, were arrested following reports that PIP used industrial g...
  • UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

    European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals process that would require the sort of marketing authorization currently given to pharmaceutical products, according to Reuters articles . "I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi, the new head of EMA. Curren...
  • TGA: PIP Implants in Australia not Likely to Rupture

    The Australian Therapeutic Goods Administration (TGA) today released statements indicating that, "there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast implants used in Australia." TGA indicated that they have received 37 reports of PIP implant ruptures (.4%), which is in line with the expected rupture rate of all implants (1% per year). Approximately 8,900 Australian women have the implants. TGA had already recalle...
  • Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

    The Poly Implant Prothese (PIP) scandal raging across Europe right now highlights the failings of regulatory agencies to effectively use post-marketing registries, claims Reuters journalist Anna Yukhananov. A registry, Yukhananov argues, would have allowed regulatory authorities around the world to identify patterns of implant failures and risks associated with the products. To date, no unified registry of breast implants exists in the United States, and US Food and Drug...