Module 12 2019

Current status of ongoing programmes: xEVMPD

NCA/ EMA

Not structured data, duplication of data, no harmonisation across systems (eAF, CTA, eCTD, CESP)

Application made by Industry:

Review by NCA/EMA

Delay & discrepency

No Structured approval

Validation process by EMA, no involvement NCAs

Some delay for information flow

Validation of Art 57 data

EMA Art 57 database

The Organisation for Professionals in Regulatory Affairs