Update to Common Technical Document (CTD) Guidance in Europe
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.