MedReg Submissions: Detailed Guide If You Are New To Healthcare Marketing

MRC, PRC, MMRC, CAT — yes, we’ll talk about Its Majesty The Submission.

In the first 3 months at my first healthcare marketing agency, I was sure I’d be fired — every single day started and ended with this thought on my mind. It is not an exaggeration. I had experience, I knew the language. BUT I didn’t have pharma experience, and I didn’t know pharma language — this paired with the fact that English was not my mother tongue made me google the whole sentences. I would write down all the words I’ve heard for the first time in my life, googled afterwards and broke them into the columns like Brand name, Generic, Accronym/Abbreviation and ????. But even this wasn’t my biggest challenge back then.

The beast of it all was The Submission. Everyone was talking about it enough for me to realize it was the integral part of the pharma marketing world, but no one explained it in detail. I tried googling (remember, google was my best friend?), but I didn’t get any results. Reference annotations, change annotations, functional annotations, submission and review dates, 2253, what can and can not be changed — my head was spinning. For some time I was thinking maybe it’s me being THAT slow, since everyone around knew what that was. But then I saw other people coming into the agency who pharma industry was new for, and they were struggling the same way that I did. I even started doing Submissions onboarding for the newcoming PMs. This post is the quintessence of the boot camp style knowledge I got in that first-months-struggle.

Disclaimer: It DOES get better!

  1. What is Its Majesty The Submission?

Every healthcare marketing piece, both for healthcare practitioners and patients, that goes in the market should be FDA-compliant from medical, legal and regulatory perspective. Reviewers need to make sure that the claims that are made in the piece are accurate and do not promise more than the data shows in the approved label.

2. Who do you submit to?

You submit to the reviewers within your client company, you are NOT submitting to FDA. Every pharma/biotech company has their MedReg board, which is comprised from the specialists in medical, legal and regulatory fields. It is never 1 person who reviews, at least 3 for each compliance direction.

3. Different names MedReg is known for

MedReg boards are abbreviated differently within each company. You will hear PRC at Gilead and PUMA, MRC at Ultragenyx, MMRC at BioMarin and Biogen, CAT at GSK — in reality, it is all the same thing.

4. Deadlines, timeframes, submission and review dates

Every company has the process set up differently, so it’s something to find out from the very start. At some companies, you have to submit by Thursday 11am for review next Thursday, which gives the MedReg board a week to review your piece prior to the live review. At other companies, it will be Friday 9am for review Wed the week after. Some will require a week for small to mid-size pieces like banners or a leave-behind, but 2 weeks and more if the piece has more than 20 pages. At others, there won’t be a hard submission day of the week and the review can take any time from 2 days to eternity.

For you, as an agency team member, the submission date, not the review, is the most important date, especially if it has a hard deadline. You can not miss it in order to stay within the timeline. If you happen to be the PM, naturally, both are equally important for you schedule.

Most MedRegs will have live reviews where review members can have a conversation with company’s marketing leads. Agencies are usually on the line, but step in only when asked by their client to do so.

If the agency already has established relationship with the client and the MedReg board, lots of reviews, especially for the straightforward pieces, will happen offline, i.e. without the official live review.

5. What exactly do you submit?

99% of submissions are happening in Veeva these days, where you submit the clean file with reference and general annotations at all times. If it’s a digital piece (website, e-mail, banners etc.), functional annotations are added to the list. If it’s a second submission (or third, fourth and down the line until final approval), you need change annotations as well.

Clean file. It’s your actual piece. If it’s a brochure, you submit a brochure. If it’s a ppt presentation, you submit a pdf of the presentation.

It gets interesting with the digital pieces, like websites, e-blasts, AR, VR, congress booths or desktop applications. You need to submit screenshots that show every single state of the digital piece. Yes, screenshots. Every drop down, accordion, every pop-up and overlay need to be screenshotted.

Reference annotations. Every claim made throughout the piece should be supported by the data. When submitting, the agency needs to mark up every single claim with the place(-s) from the reference materials these were taken from or based on. Basically, if the efficacy of the drug is 67%, the piece can not say “almost 80%”. The reference annotations help reviewers understand where the claims are coming from.

General annotations. Any general piece of information that you think will be helpful for the reviewers. For many print pieces, we annotate final printed size like 8.5x11, or the location of the pocket if any. If images are draft sketches, agency can leave a note saying that “final images will be in color, 2D animated”.

Functional annotations. Needed for digital pieces, describe functionality. F.ex. “Selecting the link opens the in a new browser tab” or “Click here to generate the qr-code”. Pretty straightforward.

Change annotations. The piece has gone through the 1st submission, agency made the changes and need to resubmit (basically, you resubmit up to the point when the reviewers do not have any comments and approve the piece). Every time you resubmit, you need to mark up the changes that have been made to the piece since the last review-not only the ones that were requested by MedReg, but every other change as well.

6. What can and can not be changed post final submission?

Almost nothing. The final piece that goes to the market should look exactly how it was submitted for final approval. That was the most difficult for me to understand once I started working in the digital healthcare. You can’t change a comma, period, color of a button. If you do — welcome to yet another submission round. Very often, working on the website f.ex. we polish the front-end, make it pixel-perfect, but leave back-end bugs for fixing while the piece is in the MedReg review. If it’s a print piece we are talking about, you can probably fix shadows, color depth for print, but that’s pretty much it.

7. Who submits?

It is run differently at every agency, but usually it’s people in one of the following roles who do the submissions — Account Manager, Project Manager, Copy Lead, special Submission Coordinator.

8. What is 2253?

Once the piece is approved by the company’s MedReg board, it needs to be filed to the FDA to be approved for distribution. That is 2253 Submission. The agency doesn’t do 2253 filing-your client company does. If you are a PM, plan for ~1 week post internal MedReg approval for getting the final final Approval for Distribution to go live.

I remember my very first submission was happening December 23rd, the day when 99,9% of the companies have a short day and let their teams go home 3pm. I stayed until 11pm. Leaving the office that day, I felt completely exhausted but happy I did manage to figure this out and not screw it up too much. It does get better, folks, just give it some time and there will be a day when you can pronounce a generic name and do 15 submissions in 5 hours for the launch!



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