An electronic Common Technical Document, or eCTD as it is more commonly referred to, offers a standard format for submitting regulatory information to health authorities. As a result, it is an integral part of how organisations within the pharmaceutical sector do business. Via an eCTD submission, organisations can share and update initial applications, responses/supplements, variations and other lifecycle sequences with regulatory health authorities, such as the FDA and EMA.
The use of eCTDs has revolutionised regulatory procedure, providing a convenient option for organisations submitting documentation and unlocking many more advantages than NeeS and paper submissions.
Whilst an efficient way to submit and update regulatory documents, making submissions can be complicated, with the difficult-to-read hierarchy a major stumbling block for many. Here we drill down into the details to help you make sense of eCTD submission. In this blog post, we focus on eCTD metadata.
What does an eCTD comprise of?
As an ICH-agreed data exchange standard, eCTDs have made the submission of content electronic. The average eCTD consists of documents in portable document format (PDF) and regional files, directory structure, and XML backbones, the latter of which replaced CTD table of contents.
How does eCTD metadata fit in?
eCTDs contain metadata to aid the lifecycle management of each file. This metadata is used to define or describe another piece of information that forms part of the submission, such as its individual components.
eCTD metadata is also known as ‘attributes’. This metadata is quite simply data about data, but its organisation and content both remain key parts of preparing an eCTD submission that will be technically approved. The consistency of the metadata is vital for a successful eCTD submission too.
What types of metadata are there?
There are two types of eCTD metadata, structural and descriptive. Structural eCTD metadata relates to the way that the content is organised with certain files requiring certain formatting for technical approval.
Descriptive metadata is the additional information or labels required for the key data that makes up the submission. An eCTD relating to a drug product for instance would be accompanied by descriptive metadata that relays its dosage and strength.
Where should metadata be included?
Metadata is supplied in different places through an eCTD. In Module 1, you’ll need to include submission-level metadata. The country, applicant, agency code, submission, procedure type, sequence and related sequence, and submission description should form part of your submission metadata for an EU application.
Across Modules 2 to 5, heading-level metadata is required. Whilst document/file level metadata is a necessity across all leaf elements throughout Modules 1 to 5.
What’s best practice for eCTD metadata?
The document granularity is a vital consideration when creating the metadata that will form part of your eCTD submission. The granularity relates to the level to which the content is broken down across multiple files within the submission. A high granularity equates to a submission made up of smaller files.
Here the European Medicines Agency (EMA) explains how document granularity plays a key role in every submission in its Harmonised Technical Guidance for eCTD Submissions in the EU:
“Submissions are a collection of documents and each document should be provided as a separate file. The detailed structure of the eCTD should conform to the ICH Granularity Document and EU M1 specification. Careful consideration is needed when deciding the level of Module 3 granularity...”
Thankfully, you don’t have to create eCTD submissions, and associated metadata, alone. Here at ONIX, we provide eCTD submission management and regulatory advisory services. For further information on how we can help, please contact us today.