Data Lock Point for PV Periodic Reports
Understanding of the Date Inclusion Criteria
Periodic Reporting is the preparation and submission of safety information(Adverse events, lack of efficacy, accidental exposure, medication error, withdrawal effects, product quality complaints, off-label use etc) about a medicinal product on a periodic or timely basis e.g every year or every 3 months or every 6 months.
Often there is a confusion regarding the date criteria for which the data would be included in a particular periodic report. This small write-up is intended to clarify the concept behind the date criteria of periodic reports.
There are 3 key dates which define the data inclusion criteria:
Development International Birth Date (DIBD)
International Birth Date (IBD)
Data Lock Point (DLP)
Development International Birth Date (DIBD)
DIBD is the date on which the sponsor gets authorization to conduct a clinical trial in any country worldwide, for the first time. If the clinical trial is going on in one country and later it is initiated in another country, the original DIBD is maintained and used for all countries for reporting purposes. Since DSUR is the periodic report for products under development, DIBD is used to determine the start of the annual period for the DSUR. Actually, the start of the annual period for the DSUR is the month and date of the DIBD.
International Birth Date (IBD)
IBD is the date of the first marketing approval for any product containing the active substance granted to any company in any country in the world. When a report contains information on different dosage forms, formulations, or uses (indications, routes and/or populations), the date of the first marketing approval for any of the various authorizations should be regarded as the IBD. This date is used for periodic reports of products that are approved and are commercially being used e.f PBRER, PSUR
Data Lock Point
Data Lock Point Date is the cut-off date for data to be included in a given periodic report or other document. .
DLP for DSURs
The data lock point of the DSUR should be the last day of the one-year reporting period. For administrative convenience, if desired by the sponsor, the data lock point of the DSUR can be designated as the last day of the month prior to the month of the DIBD. The DSUR should be submitted to all concerned regulatory authorities no later than 60 calendar days after the DSUR data lock point.
DLP for PBRER
Similarly, IBD determines the DLP for purposes of the PBRER. The DLP is the date designated as the cutoff for data to be included in a PBRER. When a separate PBRER is prepared for a fixed-dose combination product, the DLP for that PBRER can be based on either the earliest IBD of one of the component active substances, or the IBD of the first marketing approval anywhere in the world for the fixed-dose combination.
When clinical development of a drug continues following a marketing approval in any country worldwide, both a PSUR and a DSUR should be submitted as specified by national or regional laws or regulations. If desired by the sponsor, a DSUR can be prepared based on the PSUR International Birth Date (IBD) so that the DSUR and the PSUR can be synchronized. In synchronizing the data lock points for the DSUR and PSUR, the period covered by the next DSUR should be no longer than one year.