DMF Agency
Did you know that there are two types of "agents" for the FDA? They are different in the eyes of the FDA and serve different functions.
A DMF agent is "authorized to act on behalf of the DMF holder" for DMF (e)CTD submission.
A DMF agent can be a helpful single point of contact and Project Manager for a DMF eCTD submission and post-LOA review, but they are not a Regulatory Compliance requirement for foreign establishments, as opposed to a "US agent".
The FDA states:
"...An agent for DMF purposes is not the same as an agent for the purposes of the Drug Listing and Registration System. (DRLS). Holders should not include the name of the agent for Registration purposes in the DMF unless the same person or company is the agent for both the DMF and DRLS. Also note that in the US, the process of “Registration” applies ONLY to “registering” an establishment with the FDA.
All “Agent Appointment Letters” for DMFs should be signed by the holder. FDA recommends that such letters include the phrase “appoint AGENT NAME as the agent for DMF” rather than “authorize AGENT NAME to act as the agent for DMF,” since the latter can be confused with a “Letter of Authorization.”
An “Agent Appointment Letter” may be included in an original DMF.
Agents for DMF purposes are not required to be located in the United States, although this is recommended.
A different agent can be appointed for different DMFs submitted by the same holder."
Does your firm prefer or currently use a DMF agent for (e)CTD Submissions and/or post-LOA DMF review?
Saxon Interglobal offers reliable, cost-effective, Project and Risk Management-based DMF agency services that will align stakeholder functions with effective communications to reduce time and costs involved in collaborative, authoring, submission and review of your DMF.
Did you know that there are two types of "agents" for the FDA? They are different in the eyes of the FDA and serve different functions.
A DMF agent is "authorized to act on behalf of the DMF holder" for DMF (e)CTD submission.
A DMF agent can be a helpful single point of contact and Project Manager for a DMF eCTD submission and post-LOA review, but they are not a Regulatory Compliance requirement for foreign establishments, as opposed to a "US agent".
The FDA states:
"...An agent for DMF purposes is not the same as an agent for the purposes of the Drug Listing and Registration System. (DRLS). Holders should not include the name of the agent for Registration purposes in the DMF unless the same person or company is the agent for both the DMF and DRLS. Also note that in the US, the process of “Registration” applies ONLY to “registering” an establishment with the FDA.
All “Agent Appointment Letters” for DMFs should be signed by the holder. FDA recommends that such letters include the phrase “appoint AGENT NAME as the agent for DMF” rather than “authorize AGENT NAME to act as the agent for DMF,” since the latter can be confused with a “Letter of Authorization.”
An “Agent Appointment Letter” may be included in an original DMF.
Agents for DMF purposes are not required to be located in the United States, although this is recommended.
A different agent can be appointed for different DMFs submitted by the same holder."
Does your firm prefer or currently use a DMF agent for (e)CTD Submissions and/or post-LOA DMF review?
Saxon Interglobal offers reliable, cost-effective, Project and Risk Management-based DMF agency services that will align stakeholder functions with effective communications to reduce time and costs involved in collaborative, authoring, submission and review of your DMF.