JACE: post-marketing re-examination, post-marketing surveillance and manufacturing rationalisation
First written in FY2016. 2 of 4 entries say "Restated". Latest entry: FY2024.
No other company in this theme has enough history to compare yet.
- FY2024RestatedAnnual report
「Use of the product for congenital giant pigmented nevus and epidermolysis bullosa is currently subject to a use-results survey. Although the survey requires personnel and financial resources, we will provide medical institutions with the information obtained through it as appropriate, work to ensure and improve efficacy and safety, and earn the trust of medical institutions, physicians and patients.」
The company continues to ensure JACE's efficacy and safety through a use-results survey and the provision of information to medical institutions. - FY2019RestatedAnnual report
「This product is subject to 10-year use-results surveys for the indications of congenital giant pigmented nevus and epidermolysis bullosa. We will continue to provide medical institutions with appropriate information and work to ensure its efficacy and safety.」
A 10-year use-results survey is required for JACE's new indications, and the company continues to ensure post-marketing efficacy and safety by providing information to medical institutions. - FY2018-Q1AdvancedAnnual report
「In June 2017, the results of the re-examination were reported to the committee, and no changes were made to the indications, effects or performance for severe burns. This was the first time in Japan that a re-examination of a regenerative medical product had been completed.」
The results of the re-examination of JACE, based on the post-marketing clinical trial and use-results survey, were reported to the committee, showing that there were no changes to the indications or other specified attributes for severe burns. - FY2016First statedAnnual report
「During the fiscal year, we successfully completed the post-marketing clinical trial and use-results survey that had continued from the previous fiscal year, and are analysing the respective results for inclusion in the re-examination application materials. In addition, as part of our production technology development activities related to rationalising the JACE manufacturing process, we worked to reduce production costs.」
The company is simultaneously completing post-approval clinical trials and use-results surveys, analysing re-examination materials, rationalising the manufacturing process and reducing costs.