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    Dossier Gap Analysis

    A key factor in applying for a marketing authorization for a medicinal product is properly prepared registration documentation for the medicinal product (the so-called registration dossier). The registration dossier is a set of documents submitted together with the registration application needed by the competent authorities to assess the benefit-risk ratio for the proposed medicinal product and to issue a marketing authorization. The data presented in the dossier covers a wide range of information, from administrative data to detailed data on the quality, safety, and effectiveness of the medicinal product, which must be presented in the CTD format (Common Technical Document). The CTD is divided into five modules, each of which provides detailed information about the medicinal product:

    • Module 1 – contains information on administrative, regional and national matters. This module contains administrative details, such as the application form or proposed product information: Summary of Product Characteristics (SmPC), labeling, and Package Leaflet;
    • Module 2 – contains high level summaries (the Quality Overall Summary, the Non-clinical Overview/Summaries and the Clinical Overview/Summaries), prepared by suitably qualified and experienced persons (experts in a particular field);
    • Module 3 – this section of the application covers chemical and pharmaceutical data including data for biological/biotechnological products;
    • Module 4 – contains the Non-clinical Study Reports;
    • Module 5 – Clinical Study Reports.

    Detailed information on what a medicinal product application dossier should contain can be found in the Notice to Applicants (NTA).

    Even relatively minor inaccuracies in the registration dossier may delay or even suspend the issuance of a marketing authorization for a medicinal product. The best way to assess the accuracy of the registration dossier is to conduct an independent audit, also known as a gap analysis. At SciencePharma, we provide gap analysis services for medicinal product dossiers, auditing the entire documentation or limiting it to the selected scope indicated by the client. During the audit, our experts analyse and evaluate the dossier with the utmost care in terms of completeness, accuracy, as well as compliance with the law and relevant guidelines applicable in the pharmaceutical sector. A comprehensive analysis of the registration dossier helps prevent comments from registration Agencies during the registration process of a medicinal product.


    At SciencePharma a detailed dossier audit is carried out, where the following is verified:

    1. Whether the administrative part of the dossier has been prepared correctly and contains all the necessary elements of Module 1 (application form with annexes, Module 1.3 including among others Package Leaflet Readability, Test Report and Product Information, necessary declarations and statements, etc.). In the case that Module 1 is not included in the audited dossier, which is often prepared at the final stage of the work, a tabular summary of all the necessary documents is prepared. This list provides guidance on how to prepare the individual documents and indicates which documents are required in the original for each regulatory authority;.
    2. Is the medical part (non-clinical and clinical part) complete, i.e. does it contain all the necessary Modules (Module 2.2 Introduction, Module 2.4 Non-clinical Overview, Module 2.5 Clinical Overview, Module 2.6 Non-clinical Summaries, Module 2.7 Clinical Summaries and Module 4 and 5 Non-clinical Study Reports and Clinical Study Reports) or verification whether submitting documentation without any of the above mentioned Modules is justified;
    3. Does the medical part of the registration dossier (clinical and non-clinical parts) contain all the necessary data, and whether the information contained therein is factually correct. Assessment of the documentation in terms of content is crucial because it determines whether a given product has any chance of being registered for the proposed indications or population – we will assess it, and in case of any doubts, we will suggest an appropriate solution;
    4. Whether clinical trial reports (bioanalytical, statistical, integrated) meet the requirements of applicable guidelines or alternatively (in the case of certain deviations from the requirements) verification whether the medical documentation contains appropriate justification for the deviations and whether this justification is likely to be defended;
    5. Is the selected type of application correct – the registration category of a given medicinal product affects the scope of documentation submitted and, consequently, the number and type of studies necessary to be performed. We will verify whether the registration category has been selected correctly and the scope of submitted studies and data is appropriate;
    6. In the case where the documentation of the registered product refers to data for a reference product, whether the reference medicinal product has been selected properly – in order for a given product to constitute a reference product, it must meet the requirements described in Directive 2001/83/EC. An incorrectly selected reference product may mean the need to repeat time-consuming and expensive studies. We will assess the suitability of the reference product and the appropriateness of the performed studies;
    7. Is the quality part (Module 3 Quality and Module 2.3 Quality Summary) complete and contains all the necessary information – however, remember that providing too many details may lead to potential delays in the registration process or result in the subsequent need to process post-registration variations.
    8. Does the quality of the medicinal product meet the requirements of the guidelines of EMA (European Medicines Agency) and ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) – an appropriate assessment will minimize the risk of failure to meet the appropriate quality requirements, which may result not only in comments from the Agency but also rejection of the application for registration.
    9. Whether the development work performed is appropriate for a given form of medicine and the registration procedure – insufficient data from the R&D (Research and Development) stage may lead to deficiencies in other sections of Module 3 and be difficult to supplement at a later stage of the registration procedure, and identification of the problem before submitting the dossier to the Agency allows you to complete the data and correct the documentation before starting this procedure.
    10. Whether the active substance API (Active Pharmaceutical Ingredient) meets all quality requirements and the ASMF (Active Substance Master File) meets the requirements of the guidelines – inappropriate API quality may affect the overall quality and safety of the medicinal product.

    Submitting incomplete or improperly prepared documentation may result in suspension of the registration process already at the validation stage of an application or may result in many comments from the Agency and issues to be clarified, leading to delays in project implementation. After the audit, we will indicate the appropriate scope of the registration dossier and any gaps or inaccuracies. Completing these gaps before submitting the documentation for evaluation will avoid or limit the exchange of comments with the Agencies, which will undoubtedly affect the duration of the registration process.

    Why SciencePharma?

    Excellent knowledge of legal regulations as well as extensive substantive knowledge of our experts contribute to the high quality of the gap analyses we conduct. Many companies both in Poland and abroad have used our services. We have assessed dozens of registration dossiers for various categories of medicinal products planned for submission in both national and European procedures. The report prepared as part of the audit contains information on deficiencies, inconsistencies, and errors in the documentation, indicating those that may particularly raise doubts among registration Agencies. In addition, we suggest appropriate solutions and indicate the actions that should be taken to remove the deficiencies. Our extensive experience in cooperation with national registration Agencies and the EMA is also of great importance.

    Why is it worth it?

    At SciencePharma, we have qualified and experienced experts who evaluate medicinal product dossiers with attention to the smallest details. Our experts have conducted dozens of audits supporting over 20 clients in preparing a complete registration dossier, which resulted in an efficient registration process, ending with the issuance of a marketing authorization.

    The evaluation of the registration dossier prepared by our team allows us to avoid lengthy exchanges of comments with registration Agencies and thus maintain the project schedule and budget

    Do you need support in assessing whether your registration dossier can be used in the product registration process in national or European procedures? Contact us and we will prepare a comprehensive gap analysis for you. Awareness of the quality of the registration dossier will allow you to properly assess the chances of success of the registration process and adequately prepare for possible comments from registration Agencies.

    How can we help You?

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