IP Regulatory Release documentation example request

[Amrita Bains]

Is IP Regulatory Release documentation in zone 06, IP Trial and supplies the same as import or export documentation in zone 03, Regulatory? I have seen that documents can be filed in more than one location. It would be helpful to have an example of IP Regulatory Release documentation.

[Jason King-Andreini]

Hello Amrita,

Regulatory 03 is the Import/Export License application and license itself. It can include attachments which may be duplicated elsewhere in your eTMF (i.e., QP Certification, Country Specific Site Lists, etc.) however, they are fit for purpose to accompany the applications and therefore, are not duplicates – but should be attached with the application if provided.

IP Regulatory Release Documentation 06 and IP Site Release Documentation 05 are the two which I can easily find confusing. The IP Regulatory Release in 06 is all the supporting documentation your CMC Reg utilized to confirm that all the needed documents to release an IP to a country and overall for the trial is in hand (in the eTMF) – these items also, may appear elsewhere as standalone documents. I would check with your CMC Reg contributor or CRO (same function) to confirm what the release process is and how it is governed at your organization. The information they site as being confirmed to provide IP to the trial – that is what should be filed in 06 IP Regulatory Release. The 05 IP Site Release is similar, however, it is site specific and usually is comprised of a checklist (formal output from an SOP) which confirms that the sponsor has all the documents required from the site to release IP to the site. (ALERT: “…the sponsor has….” does not include – IN THE eTMF! Just because someone at your company saw the 1572, the FDF, the IDS pharmacy review, etc. doesn’t mean it has been filed. It is possibly an advantageous milestone to share that you can’t file the IP Reg Release until all the associated documentation is filed into your eTMF.

I hope that helps. Best practice to discuss amongst your teams and apply your philosophy to all the trials you are performing. Document, as you progress, specific docs you receive in this section from your contributing team and challenge when different study teams submit different materials to achieve the same objective – this could be an opportunity to harmonize your business practices.

Best,
Jason

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