I worked as an intern for a commercial technical operations team at a biopharmaceutical company, where some of the documentation I worked with was regulatory filings from different markets including the U.S., Europe, and Japan. There was some disconnect between the filings as some markets are stricter than others regarding certain aspects of the biologic, or require more documentation on manufacturing processes. This was also likely due to the staggered submission timelines. One of the ways I supported the team was review of the various biological filings with the ultimate goal of harmonization.
I was wondering how other companies go about the process of filing with multiple international agencies? In your opinion, how should this process occur? Do you believe this should be a priority consideration when preparing to submit for approval to an agency?
Finding a way to harmonize submissions in the biopharmaceutical industry is a challenge due to the varying requirements of regulatory agencies. In my experience, companies typically build a general template or "core dossier" that includes comprehensive data about the biologic. This is taken and adapted to meet the specific requirements of each market. Regulatory experts within the company work on this—whether it's the FDA in the U.S., EMA in Europe, or PMDA in Japan.
I believe that harmonizing filings across different regions should be a priority consideration. Ensuring consistency while meeting region-specific requirements can speed up approvals, minimize delays, and reduce the risk of noncompliance. Furthermore, it's efficient for long-term manufacturing and quality control. This process can also be supported by international guidelines, like those from the International Council for Harmonization (ICH), which aim to standardize regulatory expectations across regions.
However, due to staggered timelines and the evolving nature of guidelines, flexibility and continuous monitoring of regulatory updates are essential. Collaboration between teams and regulatory bodies can greatly streamline this process.
I agree that harmonizing regulatory filings is essential, and building a core dossier is an effective approach. One challenge not yet mentioned is the need to manage post-approval variations across different regions. After initial approval, regulatory agencies such as the FDA, EMA, and PMDA may impose different requirements for post-market surveillance or reporting, especially for biologics or combination products. These differences can increase the complexity of maintaining compliance across multiple markets, as each regulatory body may require distinct updates or safety reports based on local conditions and regulations.
Additionally, companies can benefit from utilizing tools like the electronic Common Technical Document (eCTD), which helps standardize submissions globally and manage the evolving regulatory landscape more efficiently. This allows for faster updates to documents, easier tracking of submissions, and more streamlined communication between regulatory bodies. As mentioned in the lecture, digital tools also enable better coordination of staggered timelines across markets, ensuring submissions remain consistent even when filing dates differ.
Considering these challenges and tools early in the filing process can help companies maintain compliance and minimize delays in multiple regions.
in my opinion, yeah, harmonizing should definitely be a priority, because the sooner you get everything aligned, the less likely you’ll run into delays or compliance issues later on. But it’s also tricky, especially when regulations are constantly being updated or when submissions are staggered across different regions.
Filing with multiple international agencies is a complex process. Harmonizing regulatory submissions across different countries is challenging, but can be aided through strategy and planning. Many companies develop a global regulatory strategy, including input from regulatory teams from each country, ensuring that the requirements of different regulatory bodies are considered early in the product development process. Companies also commonly follow common technical documentation, developed by the ICH. This standardized format simplifies preparing dossiers. Filing in multiple markets can be difficult if the approval process is not well-coordinated. Companies try to align submission timelines for critical markets, staying on top of documentation as much as possible to reduce the burden of resubmission or providing additional evidence later.
