Following a successful pilot, the European Medicines Agency's eSubmission Gateway is now live
for all applications for centralised marketing authorisations for human
medicines. This is an important milestone in the Agency's long-term strategy
for the electronic submission of applications, which aims to improve efficiency
and decrease costs for applicants.
The eSubmission Gateway is an electronic submission channel that allows
applicants to submit documents supporting all types of applications for human
medicines to the Agency securely over the internet in the Electronic Common Technical Document
(eCTD) format. Companies wishing to use the Gateway need to have access to
the Electronic Standards for the Transfer of Regulatory Information (ESTRI)
Gateway.
(eCTD) format. Companies wishing to use the Gateway need to have access to
the Electronic Standards for the Transfer of Regulatory Information (ESTRI)
Gateway.
During the pilot, which was open to a limited number of applicants from
January to April this year, the Agency saw an increase in the speed and
efficiency of the application process. This success has led to the Agency's
decision to extend the use of the Gateway to all applicants.
Full details of how to register are available on the eSubmission Gateway web page. Applicants who have already registered and used the Gateway
during the pilot can continue to submit applications without registering again.
web page. Applicants who have already registered and used the Gateway
during the pilot can continue to submit applications without registering again.
Submissions on physical media (CD or DVD) continue to be accepted as an
alternative method. However, applicants using the Gateway must not submit
duplicate submissions with physical media.
As part of the eSubmission Gateway project, the Agency is developing a
web-based submission client for low-transmission volumes, which may be more
suitable for small and medium-sized companies. This will be available by the
end of this year. It is also working on improving the functionality of the
Gateway and on providing access to a central repository of application dossiers
by medicines regulatory authorities in European Union Member States.
In parallel to the eSubmission Gateway project, the Agency is also running
a pilot of an electronic application form for certain types of application for
human and veterinary medicines. This consists of an interactive PDF form which
applicants fill out online. This pilot is running for four months until
mid-July 2012.