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    Visual representation of the eCTD (electronic Common Technical Document): Highlights how the XML component enables tracking of documentation changes and drug lifecycle. The eCTD compilation process is akin to assembling a jigsaw puzzle, where each document fits into a cohesive whole, allowing for a comprehensive view of updates and revisions.

    eCTD compilation in CP, DCP, MRP and national procedures

    What is eCTD?

    A medicine’s dossier is a collection of information about the manufacturing process, quality, efficacy, and safety. Arranging a large amount of data is important not only for its evaluation by regulatory agencies but also for the dossier’s supervision.

    The standard form of arranging dossiers is the CTD (Common Technical Document) format, which organises documents within five modules. Each document in this structure has a well-defined place and name, facilitating quick location and unambiguous identification.

    Currently, the most commonly used form of drug documentation presentation is the digitalised form of the CTD – the electronic Common Technical Document (eCTD). A particular feature of the eCTD is an XML technical component, which allows a view of past changes made to the documentation and tracking of the drug lifecycle.

    eCTD compilation is similar to putting together a jigsaw puzzle — each document is part of a logical whole. Thanks to the eCTD’s technical features, it is possible to recreate the puzzle, giving a complete picture of the changes made to the dossier.

     

    Why is this important?

    The compiled eCTD dossier is formally required in the centralised and European procedures (mutual recognition – MRP, decentralised – DCP) and preferred in the national procedures in most European Union (EU) and European Free Trade Association (EFTA) Member States. Not only the marketing authorisation dossier but also post-authorisation dossiers, such as variations, notifications or applications for marketing authorisation renewals, are published in eCTD sequences.

     

    "Diagram illustrating the eCTD dossier process: Required for centralised and European procedures (MRP, DCP) and preferred for national procedures in most EU and EFTA Member States, including marketing authorisation, variations, notifications, and renewal applications.

    The correctness of the format, naming of files and folders, and compliance of the structure of the submitted dossier with the requirements of the eCTD standard is checked in the technical validation process of the regulatory procedures. A negative validation result may lead to the need to resubmit the documentation. Taking care of the proper presentation of the prepared documents and the refinement of the sequence from a technical point of view, therefore, directly impacts the course of the conducted procedures.

    Why us?

    SciencePharma offers comprehensive support in the gathering and structuring medicinal product dossiers in eCTD format. Our knowledge of current formal requirements and the applicable guidelines guarantees the correct presentation of the dossier, according to the requirements of relevant registration agencies, for each type of procedure: centralised, European (MRP, DCP) and national. Our competence in this field allows us to prepare consistent and technically optimal eCTD sequences.

    Benefits of cooperation

    Thanks to our knowledge and practical experience, we provide effective assistance in compiling documents while meeting all legal requirements. We believe that an efficiently organised dossier not only functions as a medium for the exchange of information with regulatory agencies but also supports the marketing authorisation holder in further phases of the product life cycle.

    We ensure that the eCTD sequences we have prepared help regulatory experts navigate between sections, using the eCTD to minimise the risk of comments arising from inconsistent documentation.

    We are also mindful that the compiled dossier is intended to serve not only the registration agencies but also the marketing authorisation holder. A clearly presented dossier supports documentation management, updates and product development supervision.

    Why SciencePharma?

    eCTD compilation is a process that aims to effectively structure the extensive documentation of a medicinal product so that it is unambiguous to the regulatory authorities and supports medicine lifecycle surveillance. Entrusting us with eCTD sequence compilation guarantees that the process will be carried out with the utmost care and accuracy. Choosing SciencePharma means you can be assured that the sequence will be compliant with current standards, allowing for effective presentation of materials in the authorisation processes.

    You can also check out other Regulatory Affairs services that we provide.

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