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.
Sample 1Sample 2Sample 3
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.
Sample 1
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.
Sample 1

Examples of Clinical Trial Approval in a sentence

  • 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.

  • For instance, China requires that all clinical trials be conducted with a Clinical Trial Approval (CTA) issued by China’s State Food and Drug Administration (SFDA).

  • 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.

  • The format of drug package label is as follows: Clinical Trial Approval Letter No.: Subject No.:Investigational drug for ASC08 Tablets(For clinical trial use only, to avoid accidental ingestion by children) Number of deliveries:.Dispensing date: DD MMM YYYY.

  • Bioceros shall give access rights to Prima BioMed to the Bioceros Platform Documentation, if and to the extent required by Prima BioMed to obtain Clinical Trial Approval and/or Marketing Approval for its Products.

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

  • The Authority will review the application for renewal and issue a new Clinical Trial Approval Certificate.

  • Clinical Trial Approval The Food and Drug Regulations require licensing of manufacturing facilities, carefully controlled research and testing of products, governmental review and approval of test results prior to marketing of therapeutic products, and adherence to cGMP and principles of Good Clinical Practices, as defined by each licensing jurisdiction, during production.

  • See "Description of the Business - Intellectual Property".Clinical Development of IV SPL026 Phase I/IIaIn December 2020, the MHRA granted its Clinical Trial Approval for a Phase I/IIa clinical trial of IV SPL026.

  • 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.


More Definitions of Clinical Trial Approval

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.
Sample 1

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 any human clinical trial of a Product.

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

  • 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 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.

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

  • 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 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

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

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • 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 human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • 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 of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • 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.