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

  • 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.

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

  • Likewise, China (SFDA) has eliminated redundant import testing for small molecules as part of the Clinical Trial Authorization.

  • When the family agreed to give him$90,000, he could not pass up the opportunity.

  • 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.

  • An Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (“FDA”) and a Clinical Trial Authorization (CTA) application has been submitted in Europe, starting with Germany and Italy.

  • The general requirements for clinical trial authorization are indicated in the Clinical Trial Authorization Guideline, 2nd edition, 2017 of the Authority.

  • Applicant can refer Annex IV of Clinical Trial Authorization guideline 2017 of the Authority for required documents for import permit of investigational product.

  • Clinical Trial Authorization will be obtained prior to initiation of the study from the US Food and Drug Administration.


More Definitions of Clinical Trial Authorization

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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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 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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Related to Clinical Trial Authorization

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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 Regulatory Agency necessary for the preclinical or clinical testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Product Approval(s) 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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

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

  • 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 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 to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • 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:

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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 pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 BMS 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 required by any Environmental Requirement.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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.