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.
The regulator 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.
The Agency is also testing out electronic application forms that use an interactive PDF form which applicants fill out online and this pilot is running for four months until mid-July 2012.
• Full details of how to register are available on the EMA’s eSubmission Gateway website
