A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for:
- or in response to a request for additional information
What are the types of formats of regulatory submissions?
- Paper submissions
- Non-eCTD electronic submissions (NEES)
- Electronic submissions with eCTD
Types of regulatory submissions
- Clinical trial applications
- Requests for protocol assistance
- Post-approval studies or commitments
- Requests for orphan drug or fast-track designations
- Licensing applications for drugs, biologics and devices
- Responses to agency questions that arise during review
- Amendment/variation applications or notification submissions
What is the CTD?
The Common Technical Document (CTD) is an internationally agreed format for the preparation of applications for the registration of new medicines. These drugs are designed to be used across Europe, Japan and the United States and must be submitted to the regional regulatory authorities.
Who developed the CTD?
The Common Technical Document (CTD), was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
What is the eCTD format?
The eCTD is defined as the electronic transfer of regulatory information from industry to agency in a common format, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.
What are the benefits of the eCTD?
The benefits of eCTD are:
- A better search functionality
- The ability to track everything
- Improved reviewer efficiency
- Reduced time to approval
- Access documents across modules
- Better handling and archiving of submissions
- Repurposing of docs for submissions in other regions
- Submissions via the Electronic Submissions Gateway allows immediate receipt by FDA
Why the eCTD format?
- More accountability
- Ease of navigation and review
- Allows for going paperless
- There is less space at agencies for paper documents
- Transparency of entire submission
- eCTD is “highly recommended” by the FDA
- Single application format for all applications
- Required by EMEA for centralized procedures
- Easier decision-making process
- Increased document granularity
- eCTD is the only acceptable format for new electronic submissions to CDER and DBER.
What are the five modules of the CTD?
- Administrative and prescribing information
- Overview and CTD summaries
- Quality (pharmaceutical documentation)
- Preclinical study reports (Pharmacology/Toxicology)
- Clinical – efficacy study reports (Clinical Trials)
Get a closer look into the eCTD triangle and its modules in this blog post.
How do I file an eCTD?
If you want to file an eCTD, you have to go through the FDA Electronic Submissions Gateway (ESG) for the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). You can create an ESG account here. For Europe, you can send submissions for the European Medicines Agency (EMA) via the EMA Web Client.
What is the FDA?
The FDA stands for the Food and Drug Administration. It is a federal agency of the United States Department of Health and Human Services.
What is the EMA?
The European Medicines Agency (EMA) is responsible for protecting public and animal health by supervising and evaluating medicines in Europe
What is the MHLW?
The Ministry of Health, Labour and Welfare (MHLW) is a government aganecy that is responsible for the approval and administration of drugs, medical devices and cosmetics in Japan.
What are ASEAN regulatory authorities?
The AESAN regulatory authorities are the authorities included in the Southeast Asian Nations.
What is an ACTD?
This ASEAN Common Technical Dossier (ACTD) are the guidelines of the common format to prepare Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities (for registration of pharmaceuticals for human use.)
Is there any ideal document management system for pharmaceutical companies?
Yes, there are tools like DocShifter that make eCTD and FDA filing easy.
Any more questions about eCTD, or want to talk about an easy solution to generate eCTD friendly documents? Let us know via firstname.lastname@example.org and we’re happy to give you a demo about our DocShifter solution.