Apex Regulatory Blogspot: How to file eCTD in MRP/DCP - One decision already made?

When filing a new eCTD using the Mutual Recognition or Decentralised Procedure, you need to be aware of the following question:

“When an application refers to multiple strengths or dosage forms, should I create one eCTD covering ALL strengths and dosage forms, or should I create one eCTD for EACH?”

This is no concern under the centralised procedure, where one eCTD will be submitted to cover all dosage forms and strengths: i.e. there’s no room for discretion.The advantages and disadvantages of both approaches are discussed in the TIGes guidance, but can be summarised as follows:

For More Information please click here:Apex Regulatory Blogspot: How to file eCTD in MRP/DCP - One decision already made?