How To Determine The Performance Indicators In The PTR?


In the registration dossier CH3.5.01, it is required to provide the basis for determining the performance indicators in the Product Technical Requirements (PTR). The manufacturer shall provide the Verification and Validation Report instead of the factory inspection report. NMPA reviewers often ask the applicant to explain how the performance indicators were defined in the PTR during the supplementary phase. To avoid such issues, BradyKnows will refer to both Chinese standards and the client’s V&V reports while drafting the PTR to ensure that the performance indicator is compliant and retrievable.
Takeaway: The performance indicators listed in the PTR could be considered during type testing, hospital bidding, random national inspection, and even be referenced by the stability study reports in the research materials.