Applications under Europe’s centralised marketing authorisation
process can now be made online after the EMA’s eSubmission Gateway went
live yesterday.
The online portal is now fully open for human
medicine applications and the European pharma regulator said the move
was an important milestone in its long-term strategy to move towards
electronic applications submission.
A pilot of the Gateway
saw it opened for a limited number of applicants from January to April
this year and the EMA judged this a success, saying that the speed and
efficiency applications submitted was increased.
The pilot also saw benefits for the pharmaceutical industry, in the form of reduced costs, according to the EMA.
The
eSubmission Gateway is an electronic submission channel that allows
applicants to securely submit documents supporting all types of
applications for human medicines using 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, but those that participated in
the pilot can continue to submit applications without having to register
again.
The EMA said it would continue to accept submissions made
on physical media, such as CDs or DVDs, but doesn’t want duplicate
submissions if companies are using the Gateway.
One of the next
steps in the EMA’s eSubmission Gateway project will see a web-based
submission client developed for low-transmission volumes, which the EMA
said may be more suitable for small and medium-sized companies. This
will be available by the end of this year.
To find more information please use the below mentioned weblink
No comments:
Post a Comment