Navigating the Regulatory Complexity of Post-Approval Technical Changes in Pharmaceutical and Biotech Companies







INSIGHTS



December 7th, 2018 | Enterey

Irvine, California


In an ideal world, obtaining regulatory approval for a new product would signal that it is fit for market and that the organization’s job is done. However, drug manufacturers, distributors, and marketers know that technical changes will need to be made throughout the product’s lifecycle, and that these—notwithstanding product safety and quality—will be managed differently than those that are made pre-approval.


Post-approval technical changes (the modifications that are made to a product or process once approval to commercially sell the product has been obtained) are categorized in two ways. Changes that do not require an updated filing/notification to a regulatory body, and changes that require an updated filing/notification to a regulatory body. The second change category is where regulatory complexity arises.


Complexity: The Cause


Organizations, often by necessity, take a conservative approach to the initial filing by building maximum detail into the commercial submission. While this is often seen as the fastest route to product approval, it can also create the need to make complex technical changes post-approval. Organizations need to think strategically about their plans to handle the post-approval life cycle of the product. They should consider how their business processes are designed to support post-approval changes knowing that changes requiring a filing update are costlier and should be handled with greater scrutiny.


Complexity: Global Market


In addition to being mindful of the content of the original filings, ever changing global regulations will also need to be taken into consideration before a technical change is made. Changes to marketed products that are sold in multiple regions or countries are difficult to manage since each region or country will have its own filing and set of regulations. For instance, where the FDA might require a simple notification of a technical change which won’t affect when a product is shipped to a US destination, Japan might require prior approval before a product is shipped to Japan.


This is just one example of the different complexities that can arise around global regulations. Additional challenges arise from the fact that an idea for a technical change is developed by product experts who often do not have the expertise to know the full regulatory impact of the change they are proposing. This is why manufacturers, distributors, and marketers will need to build business processes that help bring this regulatory knowledge forward, so they efficiently and effectively consider the nuances of each country or region’s regulations prior to proceeding with a change. In some cases, approval can take multiple years to obtain. In that time, organizations may need to make additional changes, which can further complicate maintaining compliance and supply.


Complexity: Compliance and Supply


Given the varied global regulations, attempting universal compliance with all global regulations presents a significant challenge. In the life sciences industry, there are two types of compliance that are non-negotiable. The first relates to patient safety and product quality; the second relates to compliance with the filing (ensuring that what is filed within the dossier has not been affected by a technical change). Even if a technical change will not impact product quality or patient safety, failure to notify the region or country of the change might cause the organization to be out of compliance with the latest approved filing.


Although organizations strive to achieve full compliance across all their varied filings, it is very hard to do. This is where organizations should take a risk-based approach, and make strategic decisions based on thorough assessments of the level of risk tolerance they have. Generally, the bigger the market, the more risk there is in moving forward if compliance has not been achieved.


Technical changes should be evaluated within the context of the full business impact they make. In order to measure the impact, the benefit of the change should be weighed against the full cost to the organization which not only includes the cost to execute the changes, but also the cost to file and the cost to manage the supply that will be required to maintain compliance across regions that have different cycle times for approval.


Knowing when to seek help to update your processes


Navigating the nuanced territory of post-approval technical changes may feel like a minefield as you attempt to do so without specialist knowledge at hand.


So, rather than continue to bog down in the wide and far-reaching complexities that are discussed in this blog, talk to us here at Enterey first about your options. We are a team of process experts with years of experience in the field. We will help you gain control of the complexities of post-approval technical changes impacting—or threatening to impact—your organization and simplify the decisions that are coming down through it.


We are best placed to attack any issues from a ‘root cause’ perspective, and set you up to evaluate the changes that you want to make post-approval to ensure that you are not undertaking excessive changes that inherently increase your complexity. You will get peace of mind from knowing that a thorough business evaluation conducted by us will identify the necessary business process improvements that will ensure all technical changes make sense from a business standpoint.


Reach out to Enterey’s Vice President for Strategy and Business Process, Carlo Odicino who will be happy to assess your position and advise you on your next steps. You can reach him on email at carlo.odicino@enterey.com or call 949.336.5200 (x101).