Introduction to eCTD and first principles - TOPRA

Focus7References1. ICH Harmonised Tripartite Guideline, Organisation ofthe Common Technical Document for the registration ofpharmaceuticals for human use M4(R3). Current Step 4version dated January 13, 2004.2. ICH Harmonised Tripartite Guideline, The CommonTechnical Document for the registration of pharmaceuticalsfor human use, quality – M4Q(R1). Quality Overall Summaryof Module 2; Module 3: Quality. Current Step 4 version datedSeptember 12, 2002.3. ICH Harmonised Tripartite Guideline, The CommonTechnical Document for the registration of pharmaceuticalsfor human use, safety – M4S(R2). NonclinicalOverview and Nonclinical Summaries of Module 2;Organisation of Module 4. Current Step 4 version datedDecember 20, 2002.4. ICH Harmonised Tripartite Guideline, The CommonTechnical Document for the registration of pharmaceuticalsfor human use, effi cacy – M4E(R1). Clinical Overviewand Clinical Summary of Module 2; Module 5:Clinical study reports. Current Step 4 version datedSeptember 12, 2002.5. Roth, R I. Preparing the Common Technical Document forregistration of pharmaceuticals for human use (CTD)– insights andrecommendations. Drug Information Journal 2008;42:149-159.6. Schnitzler, J, Disselhoff, G, Schweim H. Drug registration: frompaper to eCTD. RAJ Pharma 2007(9).7. Powell, S. A successful transition to CTD and eCTD. RAJPharma 2007(9).8. ICH M2 EWG Electronic Common Technical DocumentSpecifi cation. ICH eCTD Specifi cation V 3.2 February 04,2004. URL: http://estri.ich.org/ectd/eCTD_Specifi cation_v3_2.pdf (Accessed August 31, 2008).9. EMEA implementation of electronic-only submissions andeCTD submissions in the Centralised Procedure: statementof intent. London, January 22, 2008. EMEA/563366/2007.10. Food and Drug Administration. URL: http://www.fda.gov/cder/regulatory/ersr/ectd.htm. (Accessed August 31, 2008).11. EMEA implementation of electronic -only submission andeCTD submission: Questions and Answers relating to practicaland technical aspects of the implementation. London, July 20,2008 EMEA/596881/2007 v0.4.ProfessionalPILProductionWe speak the right language.In anybody’s language.Luto Research Ltd103 Clarendon RoadLeeds LS2 9DFFor further informationplease contactProfessor Theo RaynorClear, concise and straight to the point. As European & UK market leadersin the creation, editing and user testing of patient information, we believethat clear communication provides better comprehension – in any language.◗ Bridging analysis & strategy◗ User testing of package leaflets for branded, generic &biotech medicines for CP, DCP or national submissions◗ PIL writing services from SmPC◗ PIL design & layout service◗ Faithful translations and linguistic validation◗ Readability testing of Risk Management Plan patienteducation materialsBringing clarity and understanding to patient information across the EU+44(0)870 126 3202solutions@luto.co.ukwww.luto.co.ukRegulatory Rapporteur – October Issue 2008