Conditional Regulatory Approval definition
Conditional Regulatory Approval means the granting of Regulatory Approval of the Licensed Product for the Field in the Territory that requires the holder of such Regulatory Approval to conduct more safety and/or efficacy studies after the initial marketing of the Licensed Product.
Conditional Regulatory Approval means a conditional or accelerated Regulatory Approval granted by a Governmental Authority after the completion of a Phase II Clinical Trial which approval adds a condition requiring the completion of a successful Phase III Clinical Trial subsequent to such Regulatory Approval.
Conditional Regulatory Approval means a Regulatory Approval granted according to Art. 14 (7) Council Regulation (EC) No 726/2004.
Examples of Conditional Regulatory Approval in a sentence
Calliditas has used and will use Commercially Reasonable Efforts to obtain Conditional Regulatory Approval and to maintain the Orphan Designation.
More Definitions of Conditional Regulatory Approval
Conditional Regulatory Approval means, with respect to a product, Regulatory Approval that requires, as a condition of such approval, any additional (or a continuation of) Clinical Trial(s) for such product in order to obtain further safety or efficacy data, including (a) accelerated Regulatory Approval in accordance with 21 CFR § 314.500 et seq. by the FDA in the United States, (b) conditional Regulatory Approval in accordance with Commission Regulation (EC) No 507/2006 by the EMA in the European Union, or (c) conditional Regulatory Approval in accordance with PSEHB/PED Notification No. 1020-1 by the applicable Regulatory Authority in Japan.