The near future of regulatory information management in Europe
By Frits Stulp, Iperion – a Deloitte company; and Aida Demneri, Deloitte
As has become all too clear at the height of the pandemic, the time needed to get a product approved and brought to market is too long and protracted in the EU. While extraordinary steps have been taken over the past two years to get vaccines and critical drugs to market safely and more quickly, much of this has been achieved by extending the working hours of evaluators. . Now that market expectations have risen, there is a new sense of urgency for the EC and EMA around transforming approval processes in a more permanent and sustainable way.
The need for sustainable transformation is not just about approving new products faster. The pandemic has also highlighted the vulnerability of entire populations to supply chain disruptions and shortages of essential medicines, and even medical devices, and the need to be able to track and manage inventories and stock movements across multiple areas. geographies in an ever more agile way.
The answer to all of these real-world challenges lies in greater data centrality supported by the adoption of new technologies, and life science companies must play their own part in driving change. But it requires the right mindset and that conversations take place and plans are implemented at the right levels.
At the clinical level, data-driven practices tend to be more advanced, but the challenge now is to standardize After game data (e.g. reference data), and to allow it to flow more freely and be used more interchangeably across functions and use cases.
In a regulatory context, the margin for improvement is considerable. So far, progress in this area has been hampered by a delay in confirming precisely what regulators will require as their own processes evolve. It’s easy to get caught up in the finer details of what the EMA is or isn’t mandated at any given time, for example.
Keep the biggest goals in sight
All the interest of doing Data rather than static documents the future of regulatory information management (and beyond) is to transform what can be done with that data, overtime and in all sorts of use cases. It also paves the way for information to be shared in different formats depending on use cases, while ensuring data consistency. (In the case of electronic patient information (ePI), the data could drive the HCP/patient friendly information population through channels other than a paper insert.)
The problem with each function continuing to own and care only for its own data is that there will always be a disharmony and overlap between information and how it is recorded and formatted between systems and the respective teams. In addition to duplicating effort, this creates the risk that the overall product “story” will contain breaks or inconsistencies or be difficult to piece together. This has implications for compliance and patient safety, as well as operational and business efficiency. (Ultimately, a life sciences company’s asset is its intellectual property, which should be strongly reflected in its product information.)
Overall – the vision that the WHO and its supporters have set out – standardized data sets that can be understood by any stakeholder and any system across the international ecosystem are transforming product traceability and transparency. They inspire confidence in all users that the information in front of them is the latest approved truth about a product and its status at any given time.
The Global IDMP Working Group (GIDWG) – whose members include representatives from the WHO, EMA and FDA – is increasingly advocating for patients, ensuring they see the benefits of international activity. It offers an algorithm-based global identifier for each product, as well as global pharmacovigilance traceability. The WHO, as a neutral party, would coordinate such a platform, a platform that doctors, pharmacists and patients around the world could trust.
Data prioritization is gaining momentum
The development of internationally recognized standards to underpin data-driven processes elsewhere in the product lifecycle is also on the cards. At the recent DIA 2022 event (strapline: Innovation through collaboration), discussions highlighted plans shared by the EMA, FDA, and PMDA of Japan to promote standardized data for CMC content, something akin to a global view of PQ/CMC. This would pave the way for the creation and more dynamic management of part of the regulatory files, and for more than one region. This would ease the work of managing variants, as a single potential use case.
This is the kind of expanded view of data use that big pharma is working towards today. Even if the regulators are not quite right yet, they know very well that this is the scenario that everything points to. So to prepare for less would be unwise.
And in fact, the adoption of data standardization is already filtering down to the national authority level in some cases. In Europe, some National Competent Authorities have hinted at plans to change their primary record review system to something that is “data ready”. They see the potential for more efficient assessments if elements of the workflow can be automated – such as information consistency checks, Marketing Authorization Holder (MAH) tracking and, perhaps be most important, to have a version of the truth of the product through the MAH and all relevant regulators.
From functional silos to an enterprise data layer
Maximizing future potential is about building product data capability that transcends individual business functions, teams, and use cases. Ideally, this means creating a non-proprietary, cross-organization data layer that receives enterprise-level funding, as this core data base will underpin the entire enterprise. Like DNA, it will contain the details of its material composition, the very essence of the company. With a transcendent, definitive, and standardized layer of data to enrich and maintain, businesses can focus their investment in data quality where it matters, while individual functional systems can call and work with the aspects of that data that are relevant to their respective activities.
Another example of the difference this will make will be that different authorities are striving for greater harmony in their treatment of medicines and medical devices and that companies are required to provide consistent data across both portfolios. (Harmonizing drug and device data management makes sense for a variety of reasons, not the least of which is the rise of combination products, which straddle the pharmaceutical and device categories. EMA is considering already actively adding device fields to its data specification in recognition of this.)
Waiting for “final clarity” on local requirements is futile
To maximize the value of today’s data investments over the long term, it follows that life sciences companies must adhere to core standards set by regulators, for example, within the framework of ISO IDMP. But waiting for the day when individual variations of this have been finalized makes no sense, as this is an ever-changing environment. Future-proofing should therefore involve sticking to the agreed core and tweaking it as needed, following an agile approach to adding functions or changing features. And of course, one of the benefits of creating a base data layer is that each set of adaptations, when they are necessary, should only be done once, at the source.
The work that needs to be done now continues to be around the investigation, evaluation, standardization and enrichment of data. Over time, the growing reliance on data – internally to the company and externally in dealings with regulators, supply chain partners, healthcare providers and ultimately patients – pave the way for process transformation. This will include increasing degrees of automation (for example, through structured routine document authoring, where current approved data is combined to create stories on the fly – even entire dynamic records – with minimal manual intervention).
It helps to approach all of this with the end goal in mind, which is the benefits to patients made possible by faster approvals, more accurate and timely drug monitoring, and more – all made possible by harmonized, consistent and reliable data, from the laboratory to real-world evidence once the products are on the market. Whatever the details of formal data-driven initiatives around the world, this must be the strategic objective and all plans must contribute to it.
Ultimately, the ability to harness data to its full potential will enable life science companies to transform not only their own operations, but also their role within the future of healthcare. This could be done by focusing more on unmet medical needs or by reducing the negative impact of ingredients and manufacturing processes on the planet.
The range of possibilities is vast.
About the authors:
Frits Stulp is Managing Director of Iperion, a Deloitte company, where he leads a team of regulatory/IDMP experts to deliver value to pharmaceutical companies as well as regulators. With over two decades of industry and consulting experience, Stulp is considered internationally as a subject matter expert on IDMP and he proactively shares his insights wherever he can. Stulp is also involved with the non-profit organization Call To Action Delivering Health Literacy (CTADHL) as part of its efforts to support transatlantic data harmonization based on the IDMP. You can reach him at email@example.com.
Aida Demneri is a partner in Deloitte’s Risk Advisory practice in the Netherlands. She leads the European and Dutch Life Sciences and Health (including MedTech) Risk Advisory and Regulatory practice. She has over 20 years of experience in risk management, regulatory affairs and compliance. With her team, she works to help clients overcome challenges on their journey to a responsible healthcare future. Specific topics include Regulatory Excellence and Transformation, Extended Enterprise Risk Management, Cybersecurity/Data and IT Quality. You can reach her at firstname.lastname@example.org.