Develop regulatory intelligence system before legal deadlines, experts say

BARCELONA – Experts noted that companies shouldn’t wait until a law is enacted to begin developing regulatory intelligence. Instead, they recommended that regulatory professionals engage with key stakeholders early to ensure they are prepared to implement the regulations and have a say in their implementation.

Regulatory factors

Bertrand Fournier, senior director for regulatory policy at Alnylam Pharmaceuticals, spoke at the RAPS Regulatory Intelligence Conference, where he discussed several factors to consider when designing a sustainable regulatory intelligence system. He mentioned three external factors for regulatory professionals to consider: the complexity of the legislative and regulatory frameworks they must comply with, the evolving scientific and technological environment, and the political environment that influences regulatory practices.

Fournier also said that regulatory affairs professionals need to consider their company's strategy in terms of potentially new regulatory regimes if they plan to expand the geographic scope of their business, and that the role of regulatory intelligence professionals is evolving. He noted that not only is there an overload of information and multiple layers of information sources, despite talk of international regulatory reliance, but many regulatory regimes are also pushing their own requirements, which is adding to the complexity of managing good regulatory intelligence.

"It's important to note that we have seen in the past years some reliance or partnership initiatives here and there, like open access, but it seems to still be an exception to the rule," said Fournier. "Every region keeps on advocating for its own regulatory approval process, and this seems to be the goal.

"Less reliance means more local legislation, more volume of legislation to process," he added.

Fournier highlighted the EU Regulatory Intelligence Network Group's definition of regulatory intelligence, which states that regulatory intelligence is "The act of processing targeted information from multiple sources, analyzing data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to feed the regulatory strategy."

Policy, intelligence, and compliance

Fournier said that while regulatory policy takes years to form and depends on how legislation is drafted and implemented, regulatory intelligence development occurs in the latter stages of legislation. As an example, he discussed the development of the EU New Pharmaceutical Legislation and noted that while the legislation began development back in 2023 with the EU Commission's proposal to create a new pharmaceutical framework, regulatory intelligence considerations about the framework weren't initiated until the EU Council amended the proposed legislation in 2025 and the tripartite agreement was reached later that year.

Fournier highlighted that regulatory professionals responsible for compliance are also part of the consideration, but they don't really come into the picture until the law is enacted and guidelines are issued based on it.

Fournier said the big takeaway is that companies should start developing a regulatory intelligence system based on the law before the final text is available.

"It's a huge piece of legislation with a massive impact on most of the functions in our companies," said Fournier. "This means that we cannot just wait for the final text to be available in two weeks from now to start the implementation, to start the gap assessment, risk assessment, and implementation.

"We are expecting more than 100 guidelines and implementing acts; there will be meetings, Q&As, and workshops. There is a wealth of information of interpretation data that will help us comply with this new regulation and directive that are going to be made available," he added. "Hence, the need for regulatory intelligence to be involved all along the way."

Engage early

Katy Thompson, director for clinical trials regulatory at IQVIA in the United Kingdom, echoed Fournier and said it's important to start considering regulatory intelligence years before a law is implemented and guidance is in draft form. She emphasized that it is important to engage with stakeholders before regulatory requirements are finalized.

"We can really start planning and engaging with industry bodies on the regulatory policy and what we would like to see change, and interpreting what is likely to come," said Thompson.

Thompson also said that it's important to engage and plan for regulatory intelligence across departments, including quality assurance, legal, pharmacovigilance, and more. She noted that each function assesses the law's impact on its own processes, and the IT team should also be considered, as they will be crucial in building the tracking system that alerts regulatory professionals to key changes.

"You need your solid database so people can extract the requirements, what documents are needed, what timelines apply... getting that information to the people," said Thompson.

Ultimately, she said that all that information needs to be fed into the roadmap that translates early insights into a working regulatory plan.

Roles and responsibilities

Fournier also noted that the roles and responsibilities of regulatory professionals in developing the regulatory intelligence system and ensuring regulatory compliance will depend on their companies' size.

When discussing how his own company is developing regulatory intelligence regarding the New Pharmaceutical Legislation, Fournier said their in-house regulatory professionals are already conducting gap analysis and impact assessments of the pre-adoption documents. He said they plan on redoing much of that work again when the final text is implemented in about two weeks' time.

Fournier said that those responsible for regulatory intelligence need to work with their colleagues responsible for regulatory compliance, regulatory strategy, regulatory policy, and other regulatory affiliates. He noted that, depending on the company's size, such tasks may be consolidated under similar titles.

Ultimately, Fournier said that the role of regulatory compliance in this situation is to assess internal regulatory processes, procedures, and systems in light of the proposed legislation. Similarly, the role of regulatory strategy is to assess the law's impact on product development; the role of regulatory policy is to inform the company's regulatory frameworks to ensure they are pragmatic and fit-for-purpose; and the other regulatory affiliates will provide guidance to determine alignment with other regulatory requirements and regional considerations.