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.
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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.
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Examples of Common Technical Document in a sentence

  • SUBMISSION FORMAT REQUIREMENTS The Electronic Common Technical Document (eCTD) is CDER and CBER’s standard format for electronic regulatory submissions.

  • The Electronic Common Technical Document (eCTD) is CDER’s standard format for electronic regulatory submissions.

  • According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert Working Group), the final report will be written according to the ICH E3 Guideline (Structure and Content of Clinical Study Reports).

  • Note: If a Common Technical Document was not prepared for Health Canada, a Comprehensive Summary may be acceptable in lieu.

  • The document is based on the World Health Organization (WHO) Guidelines on Submission of Documentation for Prequalification of Multi-source Finished Pharmaceutical Products and the International Conference on Harmonisation (ICH) Common Technical Document (CTD) requirements for Registration of Pharmaceuticals for Human Use.

  • Submission documents for regulators DMFs, as Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD).

  • Non-clinical pharmacology and toxicology data shall be submitted in a logical structure, such as the headings of the current version of Module 4 of the Common Technical Document, or the eCTD format.

  • Electronic Common Technical Document, or “eCTD” format, is the format used in applications, amendments, supplements, and reports to the FDA.

  • Clinical trial and human experience data shall be submitted in a logical structure, such as the headings of the current version of Module 5 of the Common Technical Document, or of the eCTD format.

  • Where the competent authority has publicly announced that the chemical, pharmaceutical and biological/microbiological information for the finished product may be included in the dossier in the Common Technical Document (CTD) format only, the detailed and critical summary on the results of pharmaceutical tests may be presented in the quality overall summary format.


More Definitions of Common Technical Document

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.
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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.
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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).
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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
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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).
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Related to Common Technical Document

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Information Technology means computers, software, databases, firmware, middleware, servers, workstations, networks, systems, routers, hubs, switches, data communications lines, and all other information technology equipment and associated documentation.

  • Information Technology (IT) System means the combination of hardware components, software, and other equipment to make a system whose core purpose is to accomplish a data processing need such as the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission or reception of data. IT systems include ground systems in support of flight hardware. IT systems do not include—

  • Information Technology (IT means data processing, telecommunications, and office systems technologies and services:

  • Information Technology Resources means agency budgetary resources, personnel, equipment, facilities, or services that are primarily used in the management, operation, acquisition, disposition, and transformation, or other activity related to the lifecycle of information technology; acquisitions or interagency agreements that include information technology and the services or equipment provided by such acquisitions or interagency agreements; but does not include grants to third parties which establish or support information technology not operated directly by the Federal Government. (0MB M-15-14)

  • Communication technology means an electronic device or process that:

  • Information technology services means services designed to do any of the following:

  • Information Technologies means all information processing and communications-related hardware, Software, supplies, and consumable items that the Supplier is required to supply and install under the Contract.

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • Department of Information Technology means the New Mexico Department of Information Technology which is responsible for operating the data center and all communications related items.

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Clean coal technology means any technology, including technologies applied at the precombustion, combustion, or post combustion stage, at a new or existing facility which will achieve significant reductions in air emissions of sulfur dioxide or oxides of nitrogen associated with the utilization of coal in the generation of electricity, or process steam which was not in widespread use as of November 15, 1990.

  • Contractor Software means software which is proprietary to the Contractor, including software which is or will be used by the Contractor for the purposes of providing the Services.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

  • Contractor Intellectual Property means any intellectual property owned by Contractor and developed independently from the Services.

  • Customer Technology means Customer's proprietary technology, including Customer's Internet operations design, content, software tools, hardware designs, algorithms, software (in source and object forms), user interface designs, architecture, class libraries, objects and documentation (both printed and electronic), know-how, trade secrets and any related intellectual property rights throughout the world (whether owned by Customer or licensed to Customer from a third party) and also including any derivatives, improvements, enhancements or extensions of Customer Technology conceived, reduced to practice, or developed during the term of this Agreement by Customer.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Blockchain technology means the use of a digital database containing records of

  • Intellectual Property License Agreement means the license of Intellectual Property by and between Weyerhaeuser and Newco substantially in the form attached as Exhibit B.

  • IP means Internet Protocol.

  • Intellectual Property Agreement means the agreement in substantially the form set forth as Exhibit B.

  • Authority Software means software which is owned by or licensed to the Authority, including software which is, or will be used by the Contractor for the purpose of providing the Services but excluding the Contractor Software.

  • Intellectual Property Security Agreement means the Intellectual Property Security Agreement dated as of the Closing Date among the Loan Parties and the Collateral Agent, granting a Lien in the Intellectual Property and certain other assets of the Loan Parties, as amended and in effect from time to time.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Commercial Software means Software developed or regularly used that: (i) has been sold, leased, or licensed to the general public; (ii) has been offered for sale, lease, or license to the general public; (iii) has not been offered, sold, leased, or licensed to the public but will be available for commercial sale, lease, or license in time to satisfy the delivery requirements of this Contract; or (iv) satisfies a criterion expressed in (i), (ii), or (iii) above and would require only minor modifications to meet the requirements of this Contract.