Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the currently existing standard eCTD v3.2.2, which is now used by Swissmedic. The agency states that the actual implementation of the standard may take several years. In order to simplify and accelerate the implementation of the new standard, the authority intends to partner up with medical device manufacturers to perform public consultations. For this purpose, two important documents have been issued:
- the ICH Implementation Guide as the main document describing harmonized parts of the new standard initially issued earlier in 2015, and
- The Swiss regional Implementation Guide – the document developed by Swissmedic, that contains technical requirements.
In particular, the public consultations mentioned hereinabove are related to the second document.
The authority encourages medical device manufacturers and other parties involved in operations with medical devices to provide their feedback and comments regarding the proposed documents. Public consultations will continue till September 30, 2020. Swissmedic intends to use comments received during the consultations to improve the existing regulatory framework. First of all, they will be used to optimize the Implementation Package, and its final version would be published later in December 2020.
eCTD Implementation Guide
One of the most important parts of the Implementation Package is the eCTD v4.0 Implementation Guide – the document published by the Swissmedic to provide industry representatives with information regarding the key aspects of the implementation process.
The document provides the definitions of the most important terms, namely:
- eCTD application – a collection of electronic documents compiled by a pharmaceutical company or its agent in compliance with Swiss legislation and guidelines in order to seek a marketing authorization or any amendments thereof. An eCTD application may comprise a number of submissions and submission units.
- Submission Unit – a single set of information and/or electronic documents supplied at one particular time by the applicant either as a part of or entirely complete, eCTD Application. In the context of eCTD, this is equivalent to a sequence.
- Object Identified (OID) – an OID is a sequence of numbers that uniquely identify an object and represent a hierarchically-assigned namespace. OIDs are formally defined using the International Telecommunications Union ASN.1 standard.
The present Swissmedic guidance contains detailed instructions on the implementation of eCTD v4.0. The scope of the document covers the recommended content of the submission, its structure, and the folders it should include. The regulation itself does not contain any strict requirements related to the structure of the application, so the recommendations provided by Swissmedic are voluntary.
According to the guidance, the submission should contain region-specific administrative information, as well as information about the medical device. The agency also recommends the applicant take into account the requirements published on the official website of the regulating authority.
The aspects covered by the scope of Swissmedic guidance on eCTD v4.0 implementation include, inter alia, the following ones:
- naming rules and recommendations, including the details on allowable characters,
- folder hierarchy,
- file formats (in particular, the agency recommends to used PDF format for all types of documents included in the submission),
- controlled vocabularies,
Swiss Exclusions and Country-specific Requirements
In the present guidance, Swissmedic also describes certain exclusions to be applied in case of making a submission in Switzerland.
In particular, the document contains a list of elements that should not be used in Switzerland. The list includes the following elements:
- Contact party,
- Manufactured product,
- Territorial authority,
- Product category,
- Regulatory status,
- Regulatory review time.
The agency states that the aforementioned elements should not be included in the submissions. If any of them are identified, the agency would ignore it.
Another special rule described in the guidance is related to the Submission Group – an approach to be used if the scope of the assessment includes several products. According to the guidance, in the case of the Submission Group, the appropriate information should be included in each Submission Unit. The agency states that the same regulatory procedures would be applied for all elements of the Submission Group. The document also describes the correct way the Submission Group should be included in the XML.
The authority states that all information should be submitted in a form of documents – the main elements of the submission.
Other elements the submission should contain include a keyword definition – a special element used by the applicant to define a keyword. This element should be used to provide the authority with additional information that is found necessary when assessing the case. In particular, keyword definitions could be used to improve the clarity of the document in general, especially with regard to the special terms that should not be used in the regulatory content.
Besides the aforementioned, the Swissmedic guidance also provides a wide range of detailed technical information to be taken into account by the applicant – an entity applying for marketing authorization in Switzerland. In particular, the document describes the elements to be included in the XML documents and the way they should be provided. At the same time, it is also important to mention that the agency has implemented certain measures necessary to ensure compatibility of the submissions prepared under the new standard with those prepared under the previous one.
Summarizing the information provided hereinabove the Implementation Package provides a full scope of information that would be necessary for medical device manufacturers when preparing their submission under the eCTD v4.0. The new standard also contains significant improvements in comparison to its previous version – eCTD v3.2.2. By implementing the new standard, Swissmedic intends to improve the existing regulatory frameworks and make existing regulatory procedures more effective.
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