Common Technical Document definition

Common Technical Document or “CTD” means a set of specifications for application dossier adopted by the ICH for organizing applications of pharmaceuticals for human use to regulatory authorities.

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Common Technical Document shall have the meaning set forth in the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline M4, Organization of the Common Technical Document, as revised on January 13, 2004.

Common Technical Document means the set of specifications for the application of a dossier for the registration of medicines formatted according to the International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use

Examples of Common Technical Document in a sentence

• Upon Jazz’s request, Pfenex shall provide reasonable support with respect to CMC (including writing applicable M3 modules of the International Conference on Harmonisation Common Technical Document specifically related to the production strains with respect to the applicable Product), pharmacovigilance, and other matters for the HemOnc Products in connection with Jazz’s regulatory activities.

• Licensee agrees to promptly notify Orion of any Recro Clinical Data and/or Recro Know-How generated and Recro Grant-Back Patents issued, and shall, or shall cause one or more of its Affiliates to, make available to Orion the Recro Clinical Data and/or Recro Know-How and upon Orion’s request, provide a copy of the Common Technical Document, updates thereto and other unique studies and data that supplement the Common Technical Document.

• Licensee agrees to utilize the Common Technical Document format for its marketing applications in order to facilitate any subsequent submissions filed by NovaDel or its Extraterritorial Licensee’s outside of the Territory.

• During the Term, Catalent will assist Client with all regulatory matters relating to Processing and review the Common Technical Document pertaining to the Product and make such corrections as are necessary to accurately reflect the Product, in each case at Client’s request and reasonable expense; provided, however, Catalent shall review and correct such documents as they relate to Catalent activities at no charge to Client.

• If applicable, Redhill shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government.

• This application is written in a standardized format: The Common Technical Document (CTD) format.

• Astellas shall be responsible for assembling the various sections of the Common Technical Document.

• In the Collaboration Territory, the Regulatory Lead shall be responsible for preparing and submitting the Common Technical Document (CTD) to the Regulatory Authority as agreed in the filing plan.

• Ipsen will use reasonable commercial efforts to submit the non-EU Marketing Authorization Applications at its cost as promptly as reasonable after receiving such Common Technical Document and other documents from Auxilium, provided, however, that Auxilium acknowledges that Product potential may vary from country to country or change from time to time based upon availability of competing product as well as scientific, business, marketing and return on investment considerations.

• Notwithstanding the foregoing, to the extent the Regulatory Lead is not the same Party as the Manufacturing Lead, the Manufacturing Lead shall prepare the CMC Module 3 of the Common Technical Document in English for the Optioned Product, and the Regulatory Lead will modify as appropriate, such module for use in Regulatory Approvals in the Territory.

More Definitions of Common Technical Document

Common Technical Document or “CTD” (including eCTD) means a set of specifications for application dossier adopted by applicable Regulatory Authority for organizing applications of pharmaceuticals for human use.

Common Technical Document means the document assembling all the quality, safety and efficacy information in a common format developed by the EMA, the FDA, and the Japanese Ministry of Health, Labour and Welfare; in each case, any successor agency thereto, maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Common Technical Document means the acceptable format for registration dossiers submitted to regulatory authorities within regions following the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).

Common Technical Document or "CTD" - the common technical document relating to the Candidate Product which shall be generated pursuant to the Development Program and which is sufficient to fulfill the requirements for filing an application for Regulatory Approval with the FDA and for Marketing Authorisation with the EMEA.

Common Technical Document means a harmonized structure and format for new drug product applications developed by ICH to be used by the Parties, as appropriate and subject to clinical data availability and Applicable Law in a country, in connection with Regulatory Approval Applications for Product in the European Union, Japan, Canada and the United States.

Common Technical Document means a common information format for regulatory submission in the European Union, the United States, and Japan, as defined by the International Conference on Harmonization.