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/GTWP/607698/2008
  ICH Considerations
  Oncolytic Viruses
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/536810/2008
  Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonate
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/EWP/356954/2008
  Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/EWP/30039/2008
  Guideline on the Clinical Evaluation of Direct Acting Antiviral Agents Intended for Treatment of Chronic Hepatitis C
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/EWP/321180/2008
  Appendix 1 to the Guideline on Clinical Evaluation of Diagnostic Agents (CPMP/EWP/1119/98 Rev. 1) on Imaging Agents
  Published: TGA Internet site
  Effective: 28 May 2010
• CPMP/EWP/1119/98 Rev.1
  Clinical Evaluation of Diagnostic Agents
  Replaces: CPMP/EWP/1119/98
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/QWP/396951/2006
  Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product
  Replaces: pp. 67 - 74 of Rules 1998 (3A) - 3AQ9a and CPMP/CVMP/QWP/115/95
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/381133/2009
  ICH Topic Q4B Annex 10
  Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Polyacrylamide Gel Electrophoresis
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/379801/2009
  ICH Topic Q4B Annex 9
  Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Tablet Friability
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/645592/2008
  ICH Topic Q4B Annex 8
  Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/645469/2008
  ICH Topic Q4B Annex 7
  Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Dissolution Test
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/308895/2008
  ICH Topic Q4B Annex 5
  Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/ICH/265145/2009
  Questions and Answers on ICH Topics Q8, Q9 and Q10
  Note for Guidance on Pharmaceutical Development, Quality Risk Management and Pharmaceutical Quality System
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/BWP/452081/2007
  Guideline on the Replacement of Rabbit Pyrogen Testing by an Alternative Test for Plasma-derived Medicinal Products
  Published: TGA Internet site
  Effective: 28 May 2010
• CPMP/EWP/240/95 Rev. 1
  Guideline on Clinical Development of Fixed Combination Medicinal Products
  Replaces: pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/BMWP/632613/2009
  Concept Paper on Development of a Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies
  Published: TGA Internet site
  Effective: 26 March 2010
• CPMP/ICH/5721/03
  ICH Topic Q 5 E: Comparability of Biotechnological/ Biological Products
  Note for Guidance on Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
  Replaces: EMEA/CPMP/BWP/3207/00, rev 1 (Adopted TGA May 2005)
  Published: TGA Internet site
  Effective: 26 March 2010
• CPMP/EWP/281/96 Rev.1
  Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control
  Replaces: CPMP/EWP/281/96
  Published: TGA Internet site
  Effective: 26 March 2010
  Adopted by the TGA with the following conditions:
  • "If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied"
• EMEA/359381/2009 Rev 1.1
  CHMP Recommendations for the Pharmacovigilance Plan as Part of the Risk Management Plan to be Submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine
  Published: TGA Internet site
  Effective: 26 March 2010
• EMEA/CHMP/EWP/604040/2009
  Concept Paper on the Need for a Guideline on the Clinical Investigation of Medicinal Products Intended for Treatment of Systematic and Cutaneous Lupus Erythematosus
  Published: TGA Internet site
  Effective: 26 March 2010
• EMEA/CHMP/EWP/350495/2009
  Concept Paper on the Need to Update the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03) and the Note for Guidance on the Clinical Investigation on Medicinal Products in the Treatment of Hypertension (CPMP/EWP/238/95 REV. 2) to Discuss the Need for Outcome Studies Basis on Safety Data at the Time of MAA.
  Published: TGA Internet site
  Effective: 26 March 2010
• EMEA/CHMP/CVMP/362268/2009
  Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies
  Published: TGA Internet site
  Effective: 26 March 2010
• EMEA/CHMP/BWP/134153/2009
  Concept Paper on the Need to Revise the Guideline on the Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human Use (3AB7A of July 1995)
  Published: TGA Internet site
  Effective: 26 March 2010
• 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

• CPMP/EWP/1119/98
  Points To Consider on the Evaluation of Diagnostic Agents
  Published: TGA Internet site 27 March 2002
  Status: Replaced by CPMP/EWP/1119/98 Rev.1 (Adopted by TGA 28 May 2010)
• CPMP/CVMP/QWP/115/95
  Note for Guidance on the Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal products
  Published: TGA Internet site 19 April 2001
  Status: Replaced by EMEA/CHMP/QWP/396951/2006 (Adopted by TGA 28 May 2010)
• pp. 67 - 74 of Rules 1998 (3A) - 3AQ9a
  Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product
  Published: TGA Internet site 12 February 2002
  Status: Replaced by EMEA/CHMP/QWP/396951/2006 (Adopted by TGA 28 May 2010)
• pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
  Fixed-Combination Medicinal Products
  Published: TGA Internet site 12 February 2002
  Status: Replaced by CPMP/EWP/240/95 Rev. 1 (Adopted by TGA 28 May 2010)
• EMEA/CPMP/BWP/3207/00, rev 1
  Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
  Published: TGA Internet site
  Effective: 2 May 2005
  Status: Replaced by CPMP/ICH/5721/03 (Adopted by TGA 26 March 2010)
• CPMP/EWP/281/96
  Note for Guidance on Clinical Drugs Used in Weight Control
  Published: TGA News October 2000, effective 1 August 2000
  Status: Replaced by CPMP/EWP/281/96 Rev.1 (Adopted by TGA 26 March 2010)
• 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

Guidelines NOT adopted in the last 4 months

• EMEA/CHMP/EWP/692702/2008
  Reflection Paper on Extrapolation of Results from Clinical Studies Conducted Outside the EU to the EU-Population
  Published: TGA Internet site
  Effective: 28 May 2010
• EMEA/CHMP/BWP/473191/2006 - Corr (pdf,109kb)
  Guideline on Environmental Risk Assessments for Medicinal Products Consisting of, or Containing, Genetically Modified Organisms (GMOs)
  Published: TGA Internet site 26 March 2010
• Full list of EU guidelines NOT adopted in Australia

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