![]() In the Understanding Pharma Market Access & Payers in Europe course, we explore the consequences of misaligned stakeholder messages and how to avoid. While its function is primarily to support market access teams, it is critical that the parallel development of clinical messages is consistent with those developed for payers. The development of the Value Dossier is a multidisciplinary task, with critical inputs from health outcomes, medical affairs, clinical development and marketing but it is owned overall by the global market access team. It is typically delivered to the affiliate market access colleagues some months before launch and is a distillation of the available data on current treatments and the value story of the brand or indication to support submissions and interactions with payers at the country level. Instead of submitting paper documents, the submissions are being submitted through a secured electronic portal.įor more information on how to submit a dossier or need help compiling one, please contact us for details.The Value Dossier is the core document produced by global market access teams for use by national affiliate sales and marketing organisations. ![]() The eCTD is an electronic version of the CTD. Many regulatory authorities today are mandating the submission of CTD electronically which has led to the development of eCTD guidance and requirements. Refer to the Figure below for an illustration of the CTD triangle. Module 5 details the overall clinical information such as biopharmaceutics, clinical pharmacology, efficacy, safety, benefits and risk conclusion, and study reports. Module 4 is a section detailing the overall non-clinical information such as pharmacodynamics, drug interactions, pharmacokinetics in terms of absorption, distribution, metabolism, excretion, toxicology, and study reports. This section contains the Chemistry Manufacturing and Controls (CMC) of the medical product. Module 3 details the overall quality information and is also the section for building quality in the manufacturing process. Module 2 is a summary section containing an overall summary of the non-clinical, clinical, and quality information. ![]() Since 2003, the CTD has become the mandatory format for new drug applications in the EU, Japan, Canada, and the United States. This means that ICH countries must follow the same format for these modules. Modules 2, 3, 4, and 5 are harmonized sections for all regions. Remember, each region has different requirements as to what types of administrative information should be included and how they should be organized. In general, Module 1 contains administrative information, such as cover letters, application forms, contact information, patent and exclusivity information, references, meetings, etc. For example, the FDA has a different requirement for how Module 1 should be organized and presented in comparison to those submitted in European countries. Module 1 is technically not part of the CTD because this part is not harmonized and is region-specific. The CTD is composed of 5 modules, with each module containing specific information. Many of the ICH member countries (which includes many European countries, the United States, Canada, Japan, China, etc.) are adopting the CTD in drug submissions to eliminate the need to reformat the information for submission to various different countries. This document is called the Common Technical Document (CTD). The International Council for Harmonisation (ICH) has published requirements for compiling technical documents of a medical product. The compilation of the dossier has to follow certain formats and requirements. The dossier is to be submitted to a regulatory authority for review, and approval of the submission would grant the product marketing authorization. ![]() In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. ![]()
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