Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

Should the DS and/ or DP manufacturer (CMO) look for Establishment license (EL) even if they manufacture clinical trial material and not commercial doses? Is there any applicable certification for such a facility?

My understanding is EL is required only for commercial manufacturing.

Thank you for sharing your experience.

Dear Anon,

As it pertains to US FDA Establishment Registration, it depends on the specific situation.  I have included the link for your reference so that you may confirm the requirements for the specific situation.

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

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Scott Bishop
Houston TX
United States
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Original Message:
Sent: 23-Dec-2020 08:19
From: Anonymous Member
Subject: Establishment License

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

Should the DS and/ or DP manufacturer (CMO) look for Establishment license (EL) even if they manufacture clinical trial material and not commercial doses? Is there any applicable certification for such a facility?

My understanding is EL is required only for commercial manufacturing.

Thank you for sharing your experience.

Dear Anon,

With respect to Canada, see Section 2 (exemptions) of GUI-002 (Guidance on Drug Establishment Licenses). The guide notes that 'activities that comply with an authorised clinical trial do not require a DEL, except for clinical trials involving a marketed product used according to its Health Canada market authorization, sometimes referred to as a Phase IV clinical trial'. I hope this helps. 

Kind regards,
Felicia

------------------------------
Felicia Mohammed RAC
Regulatory Affairs Manager
North York ON
Canada
------------------------------

Original Message:
Sent: 23-Dec-2020 08:19
From: Anonymous Member
Subject: Establishment License

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

Should the DS and/ or DP manufacturer (CMO) look for Establishment license (EL) even if they manufacture clinical trial material and not commercial doses? Is there any applicable certification for such a facility?

My understanding is EL is required only for commercial manufacturing.

Thank you for sharing your experience.

This message was posted by a user wishing to remain anonymous

Scott and Felicia, thank you for your responses.

Original Message:
Sent: 23-Dec-2020 08:19
From: Anonymous Member
Subject: Establishment License

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

Should the DS and/ or DP manufacturer (CMO) look for Establishment license (EL) even if they manufacture clinical trial material and not commercial doses? Is there any applicable certification for such a facility?

My understanding is EL is required only for commercial manufacturing.

Thank you for sharing your experience.