eCTDs are no new thing. This would-be global standard was launched in 2003 within the regulatory health industry to ensure both technical and regulatory requirements were met with the effectiveness and efficiency that technology allowed. Since then, the use of electronic common technical documents (eCTDs) has snowballed to unlock several advantages, including financial benefits, for organisations looking to place their human, medical device, or veterinary medicinal products on the market.
With faster review and time to market, lower cost of production and storage, and a higher rate of work efficiency part and parcel of eCTD submission, eCTD use has become a vital aspect of business for life science companies around the world. But are eCTDs mandatory?
eCTDs - mandatory or optional?
Electronic-only eCTDs became the recommended format of submissions in the centralised procedure from 1st July 2009 for the European Medicines Agency (EMA). eCTDs have since become the mandatory format for submitting initial eCTD applications, responses/supplements, variations or any other lifecycle sequences.
It officially became a legal requirement for all regulatory activities affecting National Procedures in January 2019. While the use of eCTD submissions was deemed mandatory for new Marketing Authorisation Applications (MAAs) - also known as New Drug Applications (NDAs) in the USA – a year earlier.
The Food and Drug Administration (FDA) was the latest authority to enforce the use of eCTDs, with ANDA, NDA and Master Files needing to be submitted in electronic-only formats from May 2019. Although not mandatory, the FDA strongly recommends their use as the format of choice for NDAs.
MHRA adopted mandatory eCTDs even earlier
Back in 2015 – some three years earlier than the EMA – the Medicines and Healthcare Products Regulatory Agency (MHRA) made electronic submissions mandatory. Here GOV.UK shares the announcement:
“From 1 July 2015, new market authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format. Marketing authorisation (MA) applications submitted to MHRA in non-eCTD electronic submissions (NeeS) will be rejected. Around 90% of new applications for decentralised procedures (DCP) received by MHRA are already submitted in eCTD format.”
Organisations submitting applications in ‘mutually recognised’ procedures were able to submit applications in NeeS (paper) formats for a further two years before NeeS was officially phased out in 2017.
Need assistance with eCTD submission?
With the mandatory use of eCTDs now established across most authorities, familiarising yourself with electronic-only submissions is no longer optional. Thankfully, you don’t have to negotiate the eCTD process alone. The expertise and experience of the ONIX team can provide integral support and advice from initial application to lifecycle maintenance.
We have more than 60 years of combined experience guiding clients through the complex regulatory environment, as well as the insights you need to process eCTD submissions for health authorities to approve. In fact, we’ve already assisted over 100 clients globally and have never had an eCTD technical rejection since launching our service in 2010.
By enlisting us, you need zero in-house experience, software training or dedicated staff to process applications, meaning you save time, money and resources, and can focus on drug development.
Let us take the hard work out of mandatory eCTDs. Contact our team today to discuss your requirements.