European Union guidelines
EU guidelines
- EU guidelines - ADOPTED in Australia
- EU guidelines - NOT adopted in Australia
- EU guidelines - REPLACED or SUPERSEDED (previously published as adopted)
Related information
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
Guidelines replaced/superseded in the last 4 months
- CHMP/EWP/358650/2006
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Published: TGA Internet site 8 April 2009
Status: Replaced by EMEA/CHMP/EWP/358650/2006 Corr 2 (Adopted by TGA 23 February 2010) - CPMP/EWP/4151/00
Points to consider on the requirements for clinical documentation for orally inhaled products (OIP)
Published: TGA Internet site 13 January 2005
Status: Replaced by CPMP/EWP/4151/00 Rev 1 (Adopted by TGA 23 February 2010) - Full list of EU guidelines REPLACED/SUPERSEDED in Australia