Dears,
I would like to ask for advice with regards to the submission of a MAA in EU for a gene therapy product. We would like to keep some of the quality sections confidential as part of the company's know-how (i.e. manufacturing process and development, plasmid information...).
For the CTA, we have approached several European Agencies and they agreed that confidential information may be provided in parallel with a CTA application submitted by the Sponsor. The covering letter to the confidential information should cross-reference the specific CTA application to which it relates.
We acknowledge the non applicability of Active Substance Master File (ASMF) concept to biological active substances. However, we would like to keep the confidentiality of those sections, and follow the same approach as for the CTA.
Please, does anybody know if this would be acceptable? Is there a way to keep the confidentiality of some of the quality sections?
Thank you very much in advance!
Kind regards,
María Orío
------------------------------
Maria Orio
Regulatory Affairs Associate Director
San Sebastian
Spain
------------------------------