How do i prepare a dossier

However, applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration. Asian Common Technical Documents consists of following parts.

The drug manufacturer has to submit the drug dossier in eCTD format. A NeeS format submission can normally be started with any initial, variation or renewal MA submission. Compilation The following compilation aspects are important- — The information should be specific, clear, precise and accurate. Each module could have a separate folder and in turn each section of a module could have a separate folder.

This kind of orderly arrangement will help in easy access of information and help in taking printouts of finalized copy conveniently. Similarly ensuring that various documents are designed as per ICH guidelines. This can be ensured during drafting stages of preparation of various documents. Office and Office formats cannot currently be accepted". Note that the requirements for drug and medical device submissions are quite different.

Is there a guidance document available that details the format and content requirements of the submission? Have it support navigation so the reviewer can quickly find what they need. Where applicable, consider using these elements: — Cover letter — Table of contents — Volume and page numbers — Clear headings and subheadings — Table and figure numbers, with accurate references to them from within the text — Tabs that aid quick finding of the submission sections — Reader-friendly font sizes, types and colours 34 Total views 16, On Slideshare 0.

From embeds 0. Number of embeds 3. Downloads Shares 0. Comments 0. As the European submission process moves closer to the single submission goal, we keep track of which territories still have requirements for a physical dossier submission, and all other relevant national requirements. Cyton has prepared and submitted dossiers for full, bibliographic, generic, hybrid and informed consent applications, for a wide array of different veterinary medicinal product VMP types and pharmaceutical forms.

Our teams are fully equipped to handle all other types of post-marketing applications too. Skip to main content. Dossier Preparation. A modular approach The VCP Dossier Requirements follow a modular approach which is: informed by eCTD and OECD standard dossier formats; easier to submit electronically; more efficient to screen for completeness; easier to provide the data to the appropriate experts; and contributing to collaboration and standardization.

All information must be submitted in English. Provided information may contain the history, content and samples of labeling. For promotional materials submitted as part of the post marketing reporting requirements, hypertext links to references or labeling suggested to be provided. References improve the efficiency of a review. For each application a cover letter should be provided. A comprehensive table of contents should be provided for each type of application, which may contain all module sections that have been submitted as part of concerned application.

In case of new applications, all sections should be addressed. Depending on the type of the submission relevant application form should be included in regulatory dossier. For additional part of this section can be used a signed expert reports for the different scientific parts of the dossier. The signed Expert Reports requirements presented below:. For more information and relevant templates please refer to Article 12 and in accordance with Annex I, Part I 1.

Medicinal products can be generics, hybrid products, and biosimilars. Section 1. In this case relevant legal provisions and requirements must be considered.

Only for objective and verifiable exceptions an authorization may be granted. Mentioned section is applicable for centralized procedure. The requirements in the Directive are related to use, storage and disposal of medicinal products, and they are not applicable to the synthesis or manufacture of the product.