Clinical Trial Authorization definition

Clinical Trial Authorization or “CTA” means a clinical trial authorization filed with the Medicines & Healthcare Products Regulatory Agency or EMEA as necessary to commence human clinical trials of a drug in conformance with applicable laws and regulations.
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Clinical Trial Authorization means all approvals, licenses, registrations or authorizations from the relevant Regulatory Authority necessary to conduct a human clinical trial on a Product in a country, such as authorization from the Regulatory Authority under the IND filed in the country with respect to such Product (including authorization deemed to exist under Applicable Law due to passage of the necessary amount of time from filing of the IND).
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Clinical Trial Authorization means any approvals permitting the conduct of a Clinical Trial, including (a) INDs and foreign equivalents thereof required to be obtained from a Governmental Entity; (b) approvals of IRBs; and (c) supplements, amendments, protocols and other submissions made with respect to the forgoing (a) and (b).
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Examples of Clinical Trial Authorization in a sentence

  • To the extent required by applicable laws and regulations of the European Medicines Agency (the “EMA”), the Company has submitted to the EMA a Clinical Trial Authorization or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions, if any, were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the EMA with respect to any such submissions.

  • The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization.

  • The study will not commence until a Clinical Trial Authorization (CTA) is obtained from the MPA.

  • These preclinical data were required for the provision of a Clinical Trial Authorization (CTA) and then a First-in-Man Trial (FIMT) using natural scaffolds to replace benign and malignant diseased trachea.

  • The Sponsor may require the Institution and Principal Investigator to apply for the Clinical Trial Authorization, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of ethics committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.

  • After a Clinical Trial Authorization (CTA) in Europe or an Investigational New Drug (IND) application in the US, becomes effective, Phase 1 human clinical studies may start.

  • The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorization from the Ethics Committee (“EC”) and competent authorities for the conduct of the Clinical Trial and substantial amendments to the Protocol.

  • Upon the FDA approval of an IND or the EMEA approval of a Clinical Trial Authorization with respect to such [ * ] at any time within the six (6) year period referenced in the foregoing sentence, such Patent Transferor(s) shall promptly provide the Buyer with (i) a copy of such FDA or EMEA approval and (ii) all the available and relevant data from the studies (collectively, the “Approval Notice and Report”).

  • Upon successful completion of non-clinical studies, a request for a Clinical Trial Authorization (CTA, in the EU) or an Investigational New Drug application (IND in US) must be approved by the relevant Competent Authorities for trials to be allowed to start.

  • To conduct this initial trial, we plan to file a Clinical Trial Authorization (“CTA”) with the EMA and not file with the FDA since the trial is intended to be run exclusively in Europe.


More Definitions of Clinical Trial Authorization

Clinical Trial Authorization means any issued or pending approval required to be obtained from, as applicable, a Governmental Authority, in order to conduct a Clinical Trial under applicable Legal Requirements.
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Clinical Trial Authorization means any issued or pending approval required to be obtained from, as applicable, a Governmental Authority, in order to conduct a Clinical Trial under applicable Legal Requirements. “Closing” shall have the meaning specified in Section 3.1. “Closing Date” shall have the meaning specified in Section 3.1. EXHIBIT A “Closing Date Inventory” shall mean, as of the Closing Date, the value of the Purchased Inventory as determined in accordance with the Accounting Protocol. “Closing Date Inventory Statement” shall have the meaning specified in Section 2.2. “CMO” shall mean contract manufacturing organization. “Code” shall mean the United States Internal Revenue Code of 1986, as amended. “Commercialization” or “Commercialized” means any and all activities directed to the commercialization of a product, including the preparation for sale of, offering for sale of, or sale of a product, including activities related to marketing, promoting, educating about, distributing, selling, importing and exporting such product, and interacting with Governmental Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” mean to engage in Commercialization, and “Commercialized” has a corresponding meaning. “Competing Transaction” shall have the meaning specified in Section 6.2. “Complete Data Package” shall mean (a) all Regulatory Materials and other information and documentation regarding the conduct and results of each of the Development activities relating to the Products, (b) all data, results, reports and any other information relating to, or generated from Development activities or research relating to the Products, regardless of the form in which they are created or presented, and (c) all other material data in the Selling Parties’ control generated by the Development, Manufacturing and Commercialization activities with respect to the Products, in each case, as presented in a form and substance reasonably satisfactory to Purchaser. “Confidential Information” shall mean all information of a confidential or proprietary nature (whether or not specifically labeled or identified as “confidential”), in any form or medium, whether in writing, orally, electronically or otherwise, including, but not limited to, the following: (a) internal business information (including historical and projected financial information and budgets and information relating to strategic and staffing plans and practices, business, training, marketing, promotio...
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Clinical Trial Authorization means the official written permission issued by the Kosovo Medicines Agency (hereinafter “KMA”) in the case of medicinal products and medical devices for human use and by the Kosovo Veterinary Service (hereinafter “KVS”) in the case of medicinal products and medical devices for veterinary use authorizing the sponsor and principle investigator of a proposed clinical trial to conduct the clinical trial in accordance with the provisions of Section 11 of this Law and pursuant normative acts issued pursuant to this Law.
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Clinical Trial Authorization means any issued Permit required to be obtained from a Governmental Entity or an IRB, in order to conduct a Clinical Trial in an applicable jurisdiction (including the DAL) under applicable Law (including the People’s Republic of China Provisions for Drug Registration or equivalents thereof), and including acceptance of an IND.
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Related to Clinical Trial Authorization

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Trial means any human clinical trial of a Product.

  • Environmental Authorization Any license, permit, order, approval, consent, notice, registration, filing or other form of permission or authorization required under any Environmental Law.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Prior authorization means that we must approve the Services in advance in order for the Services to be covered.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Governmental Authorization means any permit, license, authorization, plan, directive, consent order or consent decree of or from any Governmental Authority.

  • Environmental Authorizations means all licenses, permits, orders, approvals, notices, registrations or other legal prerequisites for conducting the business of the Borrower or any Subsidiary required by any Environmental Requirement.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.