List Publication of “Products that have received certification after undergoing the Consultation on Suitability of Ancillary Materials for Regenerative Medical Products”
Since 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) has established a new consultation category called “Consultation on Suitability of Ancillary Materials for Regenerative Medical Products.”
Ancillary materials whose suitability is confirmed after this consultation receive a certification from PMDA.
The FIRM Supporting Industry Committee has prepared the list of “Products that have received certification after undergoing the Consultation on Suitability of Ancillary Materials for Regenerative Medical Products” as outlined below:
However, this list is based on requests to FIRM from companies and does not comprehensively cover all the products that have obtained Certifications.
Please note the following points regarding the handling of certifications from PMDA:
Explanation of the Standards for Biological Raw Materials for human- and animal-derived ancillary materials
● Clinical trial initiation stage (at consultation meeting or at Clinical Trial Notification Submission)
– Only URL citations from the list published by FIRM (see link above) are not acceptable.
– A copy of the certification should be submitted as part of the consultation documents.
– In addition, materials such as those related to virus inactivation/removal or other documents evaluating conformity to the Standards for Biological Raw Materials should be obtained by the supplier in order to proceed with development. Please note that the certification is not intended to eliminate the need for the exchange of such information between suppliers and sponsors/investigators.
● Marketing Authorization Application Stage
– Only URL citations from the list published by FIRM (see link above) are not acceptable.
– In addition, only a copy of the certification is not acceptable. Ancillary materials such as those related to virus inactivation/removal or other documents evaluating conformity to the Standards for Biological Raw Materials must be obtained from the supplier and submitted as attached document.