Posted 26 February 2015
By Michael Mezher
In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards.
The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex. However, electronic documents provide a number of advantages over their paper counterparts, such as the potential for built-in database integration.
EMA has accepted electronic submissions of regulatory data using the electronic Common Technical Document (eCTD) format since 2003. EMA prefers that submissions use the eCTD format for the centralized procedure, and will only accept paper submissions using the Common Technical Document (CTD) in specific cases where the applicant is unable to use the eCTD format.
Despite adopting the eCTD more than a decade ago, EMA did not allow electronic marketing authorization application forms until 2012. Between 2003 and 2012, it required all submissions, whether using the eCTD or CTD, to be accompanied by paper-based application forms.
Expanding Electronic Requirements
EMA began using electronic application forms for marketing authorization applications following a pilot launched in March 2012. The agency says the forms, which require the same content as the paper versions, were improved using feedback gathered during the pilot.
Currently, both paper and electronic application forms are accepted in the EU. That will soon change, following the EU Telematics Management Board’s adoption of the Heads of Medicines Agencies’ eSubmission Roadmap in October 2014, which makes the case for transitioning to electronic-only application forms and lays out a timeline for the transition.
Broader Shift to eSubmissions
EMA is now taking steps to implement provisions of the eSubmissions Roadmap. Starting on 1 July 2015, companies will be required to use new, PDF-based, electronic application forms for all applications using the centralized procedure. The requirement will also apply to product variation and renewal applications. On 1 January 2016, the European Commission will remove the former, Microsoft Word-based, electronic forms from its website.
The agency says moving to the new forms will provide a number of benefits, including:
- “Removal of manual data extraction processes;”
- “Possibility to import data into databases;”
- “Higher data quality due to more structured data entry and usage of controlled terms;”
- “Built in business validation rules guide the applicants to fill in the forms correctly;”
- “Validation rules for the forms are in place and publicly available;”
- “Brings industry and [national competent authorities] toward a single application process.”
To support the transition to the electronic application forms, EMA has opened a user acceptance testing (UAT) period that will run until 5 March 2015.
2018: Integration and Standardization
The ultimate goal of the Roadmap is to develop a single EU-wide eSubmission portal that is fully integrated with the new electronic application forms. EMA hopes to have the portal up and running in 2018.
Due to the multifaceted nature of the eSubmission portal, the Heads of Medicines Agencies says the success of the eSubmission Roadmap will rely on stakeholder buy-in, as well as the adoption and upkeep of international standards such as eCTD v4.0 and ISO IDMP.
EMA Press Release