A Friend in Need: Managing the Complexities of Filing Submissions Globally

As anyone who works in regulatory affairs in the life sciences industry knows, it is a complex area. Not only is it cyclical in nature, with peaks and troughs that must be managed carefully, but today’s increasingly global regulatory environment means regulators are asking for more data.

By Sunshine Bruce, Global Head, Regulatory Strategy & Content Services, CSC

Pills with pill organizer.

First, regulatory can either be ramping up to deliver a submission to the regulatory authorities or it can be in maintenance mode. But even then, regulatory needs to be ready to respond to agency questions or to handle new data that could spur further submission activity. Having the resources in place to manage that workflow while not having people sitting idle in between can be difficult to manage internally.

Another significant challenge for companies – particularly those less accustomed to multiple global filings – is preparing dossiers sequentially or even at the same time. One of the things we see often is that a client will decide to file in the United States, and then shortly after will file in Europe. In some cases they try to ramp up to file in Europe within 6 months of filing that initial dossier in United States, though I’d generally recommend giving yourself a bit more breathing space!

Being Prepared

Unfortunately, this is where things can go wrong, and where it’s advisable to seek – and follow – good advice. I recall the example of a client who we advised to include additional chemistry manufacturing controls (CMC) information during the development of their U.S. application. In particular, we suggested that it would make sense to include testing and data related to their European manufacturers of the drug substance in the U.S. filing. At the time, however, they were reluctant to do so, perhaps concerned about providing unnecessary information to the authorities. So they went ahead with the initial U.S. filing, and were starting to think about how to structure the European application. Their thinking was that they could reuse multiple pieces of their U.S. application for the European one.

However, in the process of preparing for that second application they received queries from U.S. Food and Drug Administration (FDA) asking for more CMC documentation. And so while busily trying to manage their second filing they still had to fulfil the FDA’s request to answer questions within the review period in order to get approval in the United States. All the while, they were building their European marketing authorization application. Again, they didn’t take advice that the European Medicines Agency (EMA) is even more stringent about data, so they filed their European application without the additional information requested by the FDA, and after filing, they got the same questions from the EMA, only asking for even more data. They tried using the same responses that had been sent to the FDA, but by then the U.S. package was no longer sufficient.

Where it becomes critical is that in the EMA application there are very specific timelines that companies have to follow, and in some cases it can be a monumental task, especially if you’re asked to do additional testing to support a claim or because of the regulations. And if you’re in a cycle with the FDA, if the submission is still in review 1 year on, you then have to report any international filings. And that could prompt the agencies to talk to one another. While that’s not yet currently a common occurrence, it’s where the agencies are heading, which will make it even more critical to ensure the data are aligned across filings. For example, Health Canada is following the European guidelines almost to a T, which will make it easier for them to share information with one another.

Building Relationships

It’s becoming more and more important for companies to take the time to build good relationships with the agencies. During a review cycle, there are always opportunities to meet with the regulators. These meetings can be costly and time consuming, but in the long run they are hugely to the benefit of companies as it’s an opportunity to exchange information, to explain your data and position, and to truly understand what the authorities want and why.

It’s also essential to have a partner who can help you respond to the regulators, gather the data you will need – as well as information you may well be asked to provide – and then have a team that can map out all that information in order to meet commitments to the FDA or a timetable date to the EU. That’s where business process services (BPS) become the differentiator. It’s about having a team of experts that can not only work independently on specific areas – content management, regulatory affairs advice, regulatory operations – but also has the ability to seamlessly put the submissions together from start to finish.

In our next blog, Michelle Gyzen will talk about turning the data and information into a well-prepared, easy to navigate submission.

 

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