As the world continues to move towards digitalization, electronic submissions are becoming the norm for Regulatory Bodies across countries. In Europe, the European Union (EU) has established a mandatory electronic Common Technical Document (eCTD) format for the submission of medicinal products’ Regulatory information.
However, Non-EU Union-specific countries in Europe have their Regulatory Authorities, and their eCTD v4.0 requirements may differ from those of the EU countries. For a quick note, non-EU Union-specific countries in Europe include countries such as Switzerland, Norway, Iceland, and Liechtenstein, which are not part of the EU but are members of the European Economic Area (EEA) or the European Free Trade Association (EFTA).
Let us now take a look at electronic submission requirements in these countries.
Switzerland
Switzerland has mandated electronic submissions in the eCTD format from January 01, 2019. Swissmedic, the Swiss Agency for therapeutic products, has implemented the mandate to streamline the Regulatory submission process and improve the review process for Regulatory Authorities. The table below (Table 1) provides a detailed list of the specific and additional requirements for electronic submissions in Switzerland.
Table 1: Requirements for Electronic Submissions in Switzerland
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Specific Requirements
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Additional Requirements
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- Submissions must be made as per the current Swissmedic Implementation Guide on eCTD v4.0.
- Submissions must be made in the current version of the eCTD format, which is 4.0.
- All electronic documents must be submitted in PDF format, with bookmarks and hyperlinks to enable easy navigation.
- The submission package must include a complete and accurate Table of Contents.
- All electronic documents must follow Swissmedic’s technical specifications for electronic submissions.
- The submission package must include a cover letter and any necessary forms/supporting documentation.
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- The Mandatory naming convention should be followed, which includes the submission type, submission number, and sequence number.
- Specific requirements for the content and format of the various documents must be included in Module 1 of the eCTD v4.0 submission.
- Specific validation criteria must be met for a submission to be accepted. These criteria include requirements related to the structure and format of the submission, as well as specific technical requirements related to file types, file names, and metadata.
- Rules and requirements related to the lifecycle of documents must be included within the submission. For example, all documents need to be uniquely identified and versioned and document changes are to be tracked.
- Swissmedic requires all electronic submissions to be signed with a qualified electronic signature that complies with the Swiss signature law.
- Swissmedic has established specific timelines for the submission of various types of Regulatory information, such as initial marketing authorization applications, variations, and renewals.
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Source: Created by the author
Norway
The Norwegian Medicines Agency (NoMA) has adopted eCTD v4.0 as the mandatory format for all new submissions and will no longer accept submissions in the older eCTD versions. The following table (Table 2) provides an overview of NoMA’s electronic submission requirements.
Table 2: Requirements for Electronic Submissions in Norway
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Specific Requirements
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Additional Requirements
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- It is mandatory to be compliant with the eCTD standard, as defined in the International Conference on Harmonisation (ICH) eCTD 4.0 Implementation Guide.
- Submissions must be made in the eCTD v4.0 format, with all documents in PDF format.
- The submission package must include a complete and accurate Table of Contents.
- All documents must be named using a standard naming convention and must include metadata to enable easy identification and tracking.
- All documents must be bookmarked and include hyperlinks to enable easy navigation.
- The submission package must include a cover letter and any necessary forms/ supporting documentation.
- Any electronic signature must follow the Act on Electronic Signatures, 2001.
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- NoMA has established specific validation criteria for eCTD submissions to ensure that they meet technical specifications and follow the Regulatory requirements. Sponsors are strongly encouraged to use NoMA’s electronic submissions validation tool to validate their submissions before submission.
- NoMA has in place specific requirements for the content and format of the various documents that must be included in Module 1 of the eCTD submission. For example, they require the cover letter to be submitted as a separate document containing information such as the product name and registration number.
- NoMA requires each submission to be named using a specific naming convention that includes the submission type, submission number, and sequence number.
- NoMA has established specific rules and requirements related to the lifecycle of documents within the submission. For example, all documents need to be uniquely identified and versioned and document changes are to be tracked.
- NoMA requires all electronic submissions to be signed with a qualified electronic signature that complies with the Act on Electronic Signatures, 2001.
- NoMA has established specific timelines for the submission of various types of Regulatory information, such as initial marketing authorization applications, variations, and renewals.
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Source: Created by the author
Iceland
Iceland has not yet mandated the use of eCTD v4.0 for electronic submissions to their Regulatory Authority, the Icelandic Medicines Agency (IMA).
However, the IMA has been accepting electronic submissions in the eCTD format since 2014. The current eCTD version supported by the IMA is eCTD 3.2.2.
Liechtenstein
Liechtenstein is a member of the EEA and, as such, follows the same Regulatory requirements as EU countries. In EU countries, the use of eCTD for Regulatory submissions has been made mandatory for all Marketing Authorization Applications (MAA) since 2018. The current version of eCTD the EU supports is eCTD 3.2.2. It is likely that Liechtenstein also requires the use of eCTD for Regulatory submissions of medicinal products since it largely has the same requirements as the EU. It is recommended to consult the national Regulatory Agency, the Office for Public Health (Amt für Gesundheit), for more information on specific requirements and guidelines for eCTD submissions in Liechtenstein.
Compliance with eCTD technical specifications and Regulatory requirements is mandatory to ensure streamlined and efficient Regulatory submissions. Sponsors need to adhere to the specific requirements of each Regulatory Authority to ensure timely and successful submissions of Regulatory information for medicinal products.
Freyr Solutions, a global Regulatory solutions and services provider, can assist pharmaceutical companies in managing their eCTD submissions in non-EU countries. Contact Freyr for more information on eCTD submissions.
