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European Union guidelines

EU guidelines - newly published

The following guidelines have been published in the last 4 months.

Guidelines adopted in the last 4 months

  • EMEA/CHMP/EWP/484366/2009
    Concept Paper on the Need for Revision of Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression with Regard to Treatment Resistant Depression
    Published: TGA Internet site
    Effective: 23 February 2010
  • EMEA/CHMP/EWP/358650/2006 Corr 2*
    Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
    * The correction includes minor wording changes in Sections 1 and 4, an additional sentence at the end of General Recommendations under the heading Clinical Safety Evaluation of Section 4 and the additional sentence 'Alternatively, if different types of patients are included in the same trials then randomization should take place with strata defined by type of onset.' in pages 5 and 6.
    Published: TGA Internet site
    Effective: 23 February 2010
  • CPMP/EWP/4891/03
    Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis
    Published: TGA Internet site
    Effective: 23 February 2010
  • CPMP/EWP/4151/00 Rev 1
    Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents
    Published: TGA Internet site
    Effective: 23 February 2010
  • Full list of EU guidelines ADOPTED in Australia

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Guidelines replaced/superseded in the last 4 months

Guidelines NOT adopted in the last 4 months

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