Changes to CTD Guidance in Europe

Recently, a new edition of “Volume 2B Notice to Applicants: Medicinal products for human use: Presentation and format of the dossier Common Technical Document (CTD)”, Edition May 2008 (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/update_200805/ctd_05-2008.pdf) was posted on EudraLex. This replaces the June 2006 edition.

In addition to updates and correction of references, the main changes in the Notice to Applicants are:

• Addition of 1.10 Paediatrics section
• Addition of a table to M1 for generics: OVERVIEW OF THE CHOSEN REFERENCE PRODUCT FOR COMPARABILITY
• Clarification on “report justifying that the application concerns a new therapeutic indication and that significant preclinical or clinical studies have been carried out in relation to this new indication” to be placed in 1.5.3 (Extended) Data / Market Exclusivity as needed.

Application forms were also re-issued - see http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2_en.htm#2b.

Next posting will examine related changes to the EU M1 specification.