Commentary: Q&A on reliability assurance when using medical information database for approval application, re-evaluation application, etc.


On September 14, 2022, the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau at the Ministry of Health, Labour and Welfare announced the aforementioned Q&A on reliability assurance when using medical information database for approval application, re-evaluation application, etc. The Q&A on reliability, which was issued on June 19, 2019, has been withdrawn and the scope of the Q&A has been made clear that it is for registries and medical information databases. This is due to the accumulation of consultation cases for post-marketing database studies. Therefore, a portion of the Q&A has been revisited and compiled. The following is a brief explanation of the positioning of this Q&A, what was changed and what was not changed.

1. This Q&A was issued as a reliability Q&A for registries and medical information databases.

Since most of the points that are explained in this Q&A are a combination of the registry and the medical information database, it implies that the items and criteria for reliability that should be checked are basically the same. Since disease registries are created for different purposes and by different organizations, it is important to check with the registry’s management to see if this Q&A can be addressed.

2. What has changed in this Q&A

The first and most important changes that have been made are that it provided the concept of the source data and the notes to confirm how the data was obtained. There have been various views on the definition of the source data for medical information databases in discussing the reliability of medical information databases. In this Q&A, Pharmaceuticals and Medical Devices Agency (PMDA) has indicated its recognition of the health insurance association health claim data and DPC data as the source data for claims data (Q20), and it is no longer required to check the records of computer system validation regarding health claims data or output systems for DPC from electronic medical records (Q23).

The second important point is the addition of registry-specific Q&A. Most items about the registry are described in common with medical information databases, but some registry-specific Q&A as follows are also shown: Items to be confirmed with database operators when adding data that are not specified to be collected in the registry’s research protocol, etc. (Q13), points to be noted when data is entered by healthcare professionals other than physicians, etc. (Q14), confirmation regarding consent (Q15), and conformity investigations by regulatory authorities (Q16).

3. Points that have not changed in this Q&A but should be noted

Despite no changes were made, it is also important to keep in mind the reliability of clinical laboratory data (Q25). The Q25 indicates that in coding clinical laboratory data, it is necessary to understand not only the analysis material information, but also the laboratory test material and measurement method information. This explanation has not changed from the previous Q&A. Therefore, when using clinical laboratory data, it is necessary to obtain the status of each clinical laboratory item from the database provider and obtain confirmation from PMDA.

The main changes are as explained above, but for other changes, more specific examples were explained and complementary explanations were added to the previous answers. If you are considering conducting a post-marketing study, please refer to the medical information database reliability statement, the registry reliability statement, and this Q&A.

References (in Japanese):

Points to consider regarding reliability assurance in post-marketing database study for pharmaceutical products February 21, 2018

“Points to consider for ensuring reliability when using registry data for approval applications, etc.” March 23, 2021

Questions and Answers (Q&A) on points to consider for ensuring reliability when using registry or medical information databases for approval applications or applications for re-evaluation, etc. for pharmaceutical products September 14, 2022

Minoru Shimodera

President at WellDEE Consulting
Pharmacovigilance specialist certified by Japanese Society for Pharmacoepidemiology.
At MSD K.K., he was in charge of safety measures operations, use-results surveys, post-marketing database surveillances, and epidemiology-related operations. In 2021, he started his business as a real world data consultant, providing consulting services related to real world data with a focus on safety monitoring plans and post-marketing database studies.

For those considering Post-Marketing Surveillance

MDV has already discussed reliability in several post-marketing database studies with pharmaceutical companies and the PMDA and is proceeding to comply with each notice and Q&A. We also support the GPSP checklist prepared by the PMDA, so if you are considering a post-marketing database study using MDV, please contact us to inquire about our current support status and other details.

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