Clinical Trial Approval definition

Clinical Trial Approval an application to conduct clinical trials filed with, and approved by the Regulatory Authorities, prior to beginning clinical trials of a Product in humans anywhere in the Territory.
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Clinical Trial Approval means the Regulatory Approval required from the Regulatory Authority in any given country of the European Union to initiate a Clinical Trial in such country, pursuant to Directive 2001/20/EC or any enabling Laws.
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Clinical Trial Approval in mainland China, refers to the approval issued by the State Food and Drug Administration for conducting human clinical trials of drugs in China; or according to the Announcement on Adjusting the Review and Approval Procedures of for Drug Clinical Trials (No. 50, 2018) of State Food and Drug Administration and its alternative regulations, the applicant who applies for drug clinical trials in China, has not received negative or questioning comments from the Center for Drug Evaluation of State Food and Drug Administration within 60 days from the date of acceptance of the application and payment, and has carried out drug clinical trials in accordance with the submitted protocols shall be deemed to have obtained “Clinical Trial Approval”; in regions outside mainland China, “Clinical Trial Approval” refers to the approval or license issued by the drug administration departments in regions outside mainland China for conducting human clinical trials of drugs in mainland China.
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Examples of Clinical Trial Approval in a sentence

  • In addition, Clinical Trial Approval from the Health Products Regulatory Authority is required for trials involving medicinal products.

  • In addition, Clinical Trial Approval from the Health Products Regulatory Authority is required for trials involving medicinal products/medical devices within the RoI.

  • Once this classification has been confirmed the Manufacture, Clinical Trial Approval and Marketing approval (for IMPs) are under the remit of the MHRA and not the HTA.

  • Clinical Trial Approval and conduct of Good Manufacturing Practice (GMP) Inspections.

  • The NMPA promulgated the Notice of Publication of the List of Class III Medical DevicesRequiring Clinical Trial Approval 《( 關於發佈需進行臨床試驗審批的第三類醫療器械目錄的通告》) onAugust 25, 2014, which came into effect on October 1, 2014 and was amended on September 14, 2020.

  • Within Australia, Clinical Trial Approval or “CTA” is one of two schemes used by the Therapeutic Goods Administration (TGA) to authorise the supply of unapproved therapeutic goods, including medicines, medical devices and biologicals, to participants participating in clinical trials in Australia.

  • March 18, 2021 New indications of Endostar® (recombinant human endostatin injection) obtained the Clinical Trial Approval issued by the NMPA to conduct a phase III clinical study of Endostar® intrapleural injection for the treatment of malignant thoracoabdominal effusions.

  • Clinical Trial Approval (CTA)Formally known as Clinical Trial Exemption (CTX), one of two schemes used by the Therapeutic Goods Administration (TGA) to authorise the supply of unapproved therapeutic goods, including medicines, medical devices, and biologicals, to participants participating in clinical trials in Australia.

  • Upon successful review and approval of a clinical trial application, the Authority issues a Clinical Trial Approval Certificate (CTAC) with specific number and conditions on the attachment as per the template of the CTAC is attached as ANNEXURE-III.

  • The TGA administers two schemes under which clinical trials involving unapproved therapeutic goods may be conducted - The Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.


More Definitions of Clinical Trial Approval

Clinical Trial Approval means the approval by the FDA of an investigational new drug application, as defined in the U.S. Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder and/or within the EU the approval by a competent authority of a comparable filing in the EU or an EU country or the approval by another competent authority outside the US and Europe of a comparable filing in such country, in each case with respect to a Product.
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Related to Clinical Trial Approval

  • 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.

  • 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.

  • 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.

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

  • 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 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.

  • 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.

  • 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 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.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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).

  • Development approval means any written authorization from a

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Final Approval means the Court’s order granting final approval of the Settlement.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.