• China Sets Deadlines for Drug GMP Implementation

    China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry.  Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, a...
  • Additional Pharmacovigilance Guidelines Released by EMA

    The European Medicines Agency (EMA) has released its final two guidelines on good pharmacovigilance practices (GVPs) after releasing seven similar GVP guidelines on 22 June. The final two guidelines address modules III and X of proposed GVPs: pharmacovigilance inspections and additional monitoring, respectively. The first guideline, Pharmacovigilance Inspections , provides guidance on planning, conducting, reporting and following-up on pharmacovigilance inspections i...
  • EMA Releases 'Practical Guidance' for Implementation of Pharmacovigilance Legislation

    The European Medicines Agency (EMA) announced it has released what it is calling "practical guidance" in the form of a question and answer document seeking to answer some of the more common questions pertinent to pharmaceutical companies. "The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year," writes EMA. "It includes the agree...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • European Commission Demands Bulgaria 'Correctly Implement' Regulatory Legislation

    • 27 April 2012
    What happens when an EU country fails to "correctly implement" a legislative directive? A harsh scolding from the European Commission (EC) and threats to haul the country before a the European Court of Justice. That's the lesson Bulgaria is learning today, as the EC fired off a statement to the country demanding it put Directive 2009/41/EC-which regulates "activities around genetically modified micro-organisms such as when they are cultured, stored, transported, destroye...