Based on PMDA inquiries, we reviewed an existing clinical evaluation report (CER) and delivered a revised report and draft responses. Beyond editing wording, we organized the supporting information to be added to the report and handled the work from reviewing the overseas manufacturer's materials through incorporating it into the revision.
Client: Japanese medical device company
Support provided: Clinical evaluation report revision and drafting responses to PMDA inquiries
Outcome: Report and draft responses delivered
Comparing the Inquiries With the Existing Report
The client had already consulted PMDA and prepared a clinical evaluation report. The challenge was to understand the matters PMDA had asked the client to clarify and clarify what needed to be added to the report.
In addition to editing the report's wording, we examined the relationship between the inquiries and the supporting documents.
Organizing Information to Evaluate Overseas Clinical Data
The report cited clinical data from an overseas manufacturer, but needed further information to identify those materials and understand the evaluation. In addition to basic information such as document names, versions and the products concerned, we reviewed the following details.
We organized case breakdowns, treatment conditions, efficacy measures, adverse events and the relationship to comparator products, and requested the overseas manufacturer's CER and equivalence evaluation materials. This clarified the relationship between the cited data and the statements in the report.
Preparing the Revised Report and Inquiry Responses Together
Using the materials provided, we prepared and delivered a revised report and draft inquiry responses to the client. Our scope also included responding to additional inquiries received after delivery.
For those additional inquiries, we drafted responses and revised the relevant CER content, delivering the revised CER and draft responses to the client. The client informed us that, after reviewing the content, it would proceed using the materials we provided.
Outcome of This Support
In this engagement, we prepared the clinical evaluation report and draft inquiry responses and delivered them to the client. Obtaining product approval was not included in this engagement.
Related Services
・CER consulting support for Japan
Discuss Clinical Evaluation Reports and Inquiry Responses
Contact us if you need to identify information to add to an existing report or ensure consistency between the inquiry responses and the report. We will review the current report, inquiry details and available materials, then explain the scope of support.
Company and product names are withheld. The scope of additional responses depends on the request in each case.
Prepared by: MK Consulting K.K.