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    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    India Fines GSK, Sanofi for Alleged Anti-Competitive Practices

    The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...
  • Australia Launches Consultation on Protecting Trade Secrets, Confirming Clinical Data Protections

    Australia's Therapeutic Goods Administration (TGA) has become the latest global regulatory agency to look to better define what it considers to be commercially confidential information (CCI), launching a new consultation on 27 June 2013 that explains in extensive detail what such information is-and just as importantly, is not. Clinical Trials Data: It's Confidential The document, Draft TGA Approach to Disclosure of Commercially Confidential Information , may be mos...
  • EMA, HMA Release Joint Guidance Document on Commercially Confidential Information in MAAs

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced 27 March they have adopted a joint guidance document that will provide a "consistent Europe-wide approach to the identification of commercially confidential information and personal data in a marketing authorization application." "In [the] future, regulatory authorities in the European Economic Area (EEA) will apply the same principles to identify which parts of an application dossier...