Covid has spurred regulators towards a more agile and innovation-supporting future, paving the way for new opportunities for all. If life sciences companies embrace a data-driven approach to managing their product data now, they stand to reap the broadest benefits, including more robust and streamlined internal processes, supply continuity, and a level of transparency that really puts the patient first. Frits Stulp and Aida Demneri, partners at Deloitte, explore what’s possible.
In light of the pandemic, there is a new sense of urgency within the EC and EMA around transforming approval processes so that expedited approvals don’t continue to rely on reviewers working overtime.
The need for lasting transformation isn’t just about approving new products more swiftly. The pandemic also highlighted entire populations’ vulnerability to breaks in supply chains and shortages of critical medicines, and indeed medical devices, and the need to be able to track and manage inventories and stock movement across multiple geographies in ever more agile ways.
The answer to all of these real-world challenges lies in greater data centricity supported by the adoption of new technologies, and life sciences companies must play their own part in driving change. But this requires the right mindset, and that conversations and plans are happening and being enacted at the right levels.
Looking Beyond the Guidance
Tracking the granular details of what EMA is or isn’t mandated at any given time can be a distraction, as companies develop and execute their own data-first strategies. After all, the whole point of prioritising data over static documents is to transform what can be done with that information, over time and in all kinds of use cases. It also paves the way for information to be shared in different formats while maintaining its integrity. (In the case of electronic patient information (ePI), the data might drive the population of HCP-/patient-friendly information through channels other than a paper insert, for instance.)
This has organisational implications, which companies could be tackling now. Should Regulatory Affairs or the company’s RIM lead automatically continue as the owner of the master data source, given that regulatory applications are just one aspect of the product lifecycle? In the bigger picture – the vision WHO and its supporters have set out – standardised data sets, which can be understood by any stakeholder and any system across the international ecosystem, transform 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. This suggests a move away from running multiple, discrete systems each drawing from its own, slightly different data repositories.
Data Harmonisation is a Global Goal
There is another consideration for teams that have become too deeply preoccupied with the specifics of EMA’s IDMP implementation roadmap. The development of internationally agreed standards to underpin data-driven processes elsewhere in the product lifecycle is on the cards, too. At the recent DIA 2022 event, discussions included the evolution of shared plans by EMA, FDA and Japan’s PMDA to promote standardised data for CMC content, something akin to a global take on PQ/CMC. This would pave the way for one part of regulatory dossiers to be created and managed more dynamically, and for more than one region (potentially making lighter work of variations management, as just one potential use case). It’s this kind of expanded vision for data use the major pharma companies are working towards today, appreciating that this is the scenario that everything is pointing towards (so to prepare for anything less would be unwise). And actually, the adoption of data standardisation is already filtering down to a national authority level in some cases.
