Health Canada, the Canadian authority responsible for medical device regulation, published a notice announcing the implementation of the electronic Common Technical Document (eCTD) format. The appropriate pilot project commenced in August 2019, and now the authority informs that the success reached in a pilot project creates a basis for the actual implementation of the eCTD format in regulatory activities connected with clinical trials.
eCTD Format: Brief Overview
The electronic Common Technical Document (eCTD) standard was initially developed by the International Conference on Harmonisation (ICH) to cover aspects related to transmitting information in an electronic format. In particular, the standard outlines the requirements that are applicable to communication between the industry representatives and regulating authorities.
According to the guidance document on the preparation of submissions in eCTD form that was previously issued by the authority, it is recommended to use the eCTD format in cases related to drug-medical device combination products, while in case of medical device-drug combination products the eCTD format should be used just for the drug components of such devices. The requirements for regulatory activities performed with the use of the new eCTD format are the same as ones applied to the general applications filed in the traditional paper form. Thus, the document should comply with the general requirements for the Common Technical Document Format described by the authority in the appropriate guidance document.
The eCTD form itself is based on the utilization of the eXtensible Markup Language (XML). At the same time, it is advised to supplement all transactions with appropriate cover letters. The cover letter accompanying the submission should contain the following elements:
- The description of the information provided and the reason it is provided,
- References to any prior communications with the regulating authority,
- Reference to the request letter (if applicable),
- The name of the manufacturer or the applicant,
- The name of the brand,
- Control number and Dossier Identified,
- The indication of the particular type of regulatory activity,
- Sequence number,
- Information about any related regulatory activities,
- Contact details, including the name and email address.
The Scope of eCTD Implementation
According to the notice published by the authority, the eCTD format would be implemented for the following regulatory activities:
- Pre-Clinical Trial Application Consultation Meeting (PRE-CTA),
- Clinical Trial Applications (CTAs),
- Clinical Trial Applications – Amendments (CTA-As),
- Clinical Trial Application – Notification (CTA-N),
- Any and all regulatory responses and the post-clearance data related to the abovementioned activities.
At the same time, the new eCTD format would still not be applicable for some activities, namely:
- Clinical Trial Site Information (CTSI),
- Development Safety Update Report (DSUR),
- Requests from the Therapeutic Products Directorate / Office of Clinical Trials – Adverse Drug Reaction division (OCT ADR), related to the adverse events and the appropriate assessment of the information related thereto,
- Fax-Backs for the Biologics and Genetic Therapies Directorate.
In accordance with the current regulatory requirements, the new approach is voluntary, so the applicant may either use the eCTD format or continue using the previous data submission format. At the same time, the authority additionally emphasizes that in case if an applicant once used the new eCTD format, all further communications related to the appropriate matter should be performed using the eCTD format too, and there would be no way to use standard format anymore. To file the communications in the new format, an applicant must use the Common Electronic Submissions Gateway (CESG).
The authority also provides particular recommendations that the applicants should consider when filing the information using the eCTD format. In particular, the use of the eCTD format is connected with the following aspects:
- It is required to file a sample transaction to the authority in a way prescribed by the guidance before filing the original documents related to clinical trials using the eCTD format.
- It is also advised to arrange a Pre-technical meeting with the authority to discuss the issues related to the use of the eCTD format.
- Upon the confirmation from the authority stating that the eCTD sample has been duly received, an applicant will be able to file a request to the authority to provide a Dossier Identifier using the Dossier Request Form for Clinical Trials dossiers.
- The authority informs that a set of supplementary documents has been developed to assist medical device manufacturers and other parties involved in using the new eCTD format, including the guidance documents dedicated to the lifecycle management, the use of the eCTD format for clinical trial applications, and the description of the clinical trial regulatory transactions.
Common Electronic Submissions Gateway
According to the information published by the authority, as of January 1, 2020, all documents provided to the authority using the Common Electronic Submission Gateway (CESG). The CEGS is the special system intended to establish a safe gateway to be used by the applicants when submitting documents to the regulating authority. The system itself has been initially developed in collaborations with the US Food and Drug Administration and is actually based on the approach used for the FDA2s Electronic Submissions Gateway. It was first introduced in February 2014, and now should be used for all types of transactions related to the regulated activities. The authority states that all regulatory transactions related to the new Master Files should be performed in the eCTD format, while for the existing Master Files the use of the eCTD format would be preferable but still is not obligatory at the moment. At the same time, if the transactions exceed the 10 GB threshold, the information should be provided on the media carrier regardless of the appropriate requirements related to the use of the eCTD format.
To be able to use the gateway, an applicant shall perform the following steps:
- To complete the registration as a Trading Partner with Food and Drug Administration by registering for a WebTrader or an AS2 account with the FDA Electronica Submissions Gateway (ESG).
- To submit the information to the Canadian authority using the FDA’s ESG indicating the “HC” as the center. In this case, the information would be redirected to the Canadian authority.
The authority states that the implementation of the eCTD together with the CESG would substantially simplify the information exchange between industry representatives and regulating authorities since it would be possible to submit the information to both US and Canadian regulating authorities simultaneously. It would also allow the reduction of costs associated with filing submissions, as well as the flow of the paper documents related to the regulatory transactions.
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