Decentralised procedures – how to prepare good applications - Elisabeth Penninga
1:30 PM - 2:10 PM
The decentralised procedure was introduced by Directive 2004/27/EC. Decentralised procedures are application procedures including a few or several European countries simultaneously. In contrast to the centralised procedures, which are assessed and approved by the CHMP, the decentralised application will be assessed and approved by Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which is a committee under the EMA.
When applying via a decentralised procedure, it is important to choose appropriate legal grounds for the procedure, as new applications can be submitted according to different procedures. The Sponsor can choose to apply with a full application according to Article 8(3), with a generic application according to Article 10(1), or with a bibliographic application according to Article 10(a).
Selection of the appropriate procedure raises several important considerations and depends on the data set supporting the application. A full application needs data from clinical trials, but this is not needed for bibliographic applications. For all applications, it is important, that all relevant parts of the application are correctly and sufficiently addressed, however, it is often difficult to estimate what is necessary for an application to be considered adequate.
This session will take the participants through the different procedures, pit-falls for the applications and most importantly, how to prepare a good application and thereby increase the possibilities for a smooth procedure and a positive opinion.