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Submitting Drug Master File Submissions to Health Canada – Lessons Learned

November 7, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

Health Canada has recently announced two major initiatives which greatly affect regulatory submissions in general and Master Files (commonly called Drug Master Files) specifically.

First, Health Canada will now require that all electronic submissions (under 10 GB in size, which is most of them) be sent via their Common Electronic Submissions Gateway (CESG) effective January 1st of 2017. Note that this is 4 months ahead of the FDA’s mandate of May 5th, 2017 (see our previous post for details).

Second, Health Canada has released draft guidance on Master Files with very detailed changes to how they are laid out and submitted. It is very different from FDA Drug Master Files; one example is the Applicant’s Part/Restricted Part (as described below). If you haven’t read the guidance and are considering submitting to Health Canada, I urge you to read it.

In light of all this, and since IMPACT’s Regulatory Operations group has recently published and submitted a series of Master Files to Health Canada, I thought this was a good time to share what we learned, and what you should know, when submitting there.

Setting up a Health Canada CESG account

picGood news! If you have an FDA ESG account, you can use that to submit to Health Canada as well —you don’t need a separate account!

Simply log in to your ESG account as you normally would and create a new submission (Webtrader→Send document). In the drop-down menu to select the center (CDER, CBER, etc.) you’ll see HC listed (as shown to the right). Select it from the list and submit as you normally would. The ESG will route your submission to Health Canada.

If you don’t have an FDA ESG account, and would like to set one up, read our earlier post for instructions on how to do just that.

Pilot review process

Even though you don’t have to apply for a Health Canada CESG account as you do for the FDA ESG, you do have to submit a pilot application for each DMF type that you plan to file. From our experience, let me say that HC does a very detailed review of your pilot!

Health Canada will offer detailed feedback on leaf titles, content placement, and eCTD metadata. Depending on the complexity of your filing, the pilot review process could take 3 to 4 weeks. Our first pilot took about 3 weeks to get approved, though that was a very complicated Master File which hadn’t been written in eCTD format so there was a lot of editing.

And no, you can’t submit the real sequence until the pilot has been approved.

Based on our experience, here are our two recommendations:

  1. We recommend that you submit the real content as your pilot. Once the pilot is approved you simply change the application number to that of your real one and you’re good to go.
  2. Build a few rounds of review into your timeline; don’t expect that your pilot will just fly through on the first attempt!

Applicant’s Part/Restricted Part

Depending on the type of Master File you’re submitting (Type I through IV) you may have to provide a Restricted Part (formerly called the Closed Part) and an Applicant’s Part (formerly called the Open Part).

Again, this is very different from FDA Drug Master File submissions so take a good look at the guidance and possibly contact the Master File Administrative Unit before you get started. A few of our recent submissions did require this format so we reached out to them for guidance along the way.

The good news is that the people at Health Canada were extremely helpful guiding us through our first one—it really felt like they wanted us to submit the best possible Master File, and not just for their sake but also for ours. Having gone through this a few times now it has become much more routine.

We hope this information is helpful to you. But if you need further help, please don’t hesitate to contact us!

Category: Regulatory Operations
Keywords: Health Canada, Master Files, Drug Master Files, Common Electronic Submissions Gateway, CESG, Applicant Part, Restricted Part

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