Post-Marketing Surveillance means post-marketing surveillance required by a Regulatory Authority in Japan to ensure the efficacy and safety of Products after Marketing Approval of such Products and to establish proper methods of use of Product, consisting of three systems: the adverse drug reactions and infections collection and reporting system, the reexamination system, and the reevaluation system in Japan. 12 Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets and three asterisks [***], have been separately filed with the Commission.
Examples of Post-Marketing Surveillance in a sentence
Distributor shall maintain a Post-Marketing Surveillance Program.
Post-Marketing Surveillance shall mean all post-marketing safety surveillance in the Initial Territory with respect to the Product that is required by a Regulatory Authority in the Initial Territory or any Additional Territory in which the Products are being Developed or Commercialized.
Takeda shall be responsible for the reporting of Adverse Experience Data obtained from the Post-Marketing Surveillance, Phase IV Studies and any clinical trials conducted by it for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory.
K., ''Approaches to Evaluating Causation of Suspected Drug Reactions,'' In ''Drug Epidemiology and Post-Marketing Surveillance,'' edited by Strom, B.
MTPC will provide all protocols for all clinical trials with respect to the Product in the Field in the Territory, including post-marketing non-approval trials, but excluding Post-Marketing Surveillance, to the JDC, within the timeframes and in the manner described in the Regulatory and Development Document Appendix.