According to PMLive, from last month, European applications for human medicines marketing authorizations can be made on-line via the EMA eSubmission gateway, following a successful 4 month pilot period. This should speed up the processing of marketing applications
The eSubmision gateway is an electronic submission channel that allows applicants to securely submit electronic documents supporting all types of applications for human medicines using the Electronic Common Technical document (eCTD) format.
Those wishing to use the gateway, need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) gateway by registering to use it, unless they were already involved in the pilot use
Later this year, there should also be a web-based submission client developed especially for low transmission volume customers, which would suit small and medium companies
The EMA will continue to accept submissions made on physical media such as CDs or DVDs, for those who prefer to use physical media but the EMA does not want to see duplicated transactions using both media
The EMA is presently testing out via a pilot study until July 2012, electronic application forms that use an interactive PDF form which applicants can fill out on-line
These developments should in due course speed up the marketing application process whilst keeping the process and data secure