MedDRA MSSO - Comment

The MedDRA MSSO appreciates the opportunity to comment on this Proposed Rule for Postmarketing Safety Reporting for Combination Products. Several MedDRA subscribers have commented to the MSSO that they welcome the clarification that the rule provides with respect to the applicable reporting requirements and the Centers to which the reports are to be submitted. However, while the rule references the relevant regulations, it is not clear whether there are any specific requirements regarding the terminologies to be used for reporting to each Center. For example, if a report is submitted to CDER for a combination product approved under an NDA and the event is associated with the device constituent part, then the reporting requirements for devices apply but does that mean that CDRH Device Problem Codes must be used for the device event? Similarly, if a report is submitted to CDRH and the event is associated with the drug or biological product constituent part, then the reporting requirements for drugs and biologics apply but does that mean MedDRA or another clinical terminology must be used for the drug/biological product event, and not CDRH Patient Problem Codes? We recommend that the rule should provide explicit guidance on the applicable terminologies required by each set of regulations for events associated with the device or drug/biological product constituent parts. In addition, it would be helpful if the rule could cross-reference and be harmonized with the Proposed Rule for Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.