Digital solutions are already being rolled out in pharma R&D and pharmacovigilance, but the regulatory process remains largely manual and time consuming, with slow adoption of innovative digital approaches. However, new solutions are being developed to facilitate digital transformation in the regulatory environment. The combination of smarter working processes and proper use of innovative technologies will drive efficiencies in regulatory submissions while keeping high standards of quality and compliance. Ultimately this could translate into time and resource savings for marketing authorisations and post-marketing requirements that will revolutionise the regulatory environment.
Regulatory affairs is often perceived as traditionally conservative, with a heavily manual workload requiring human input for many repetitive tasks during operations. Companies providing regulatory software solutions have been driven by the needs of these manual processes, focusing on the simplification of manual tasks and supporting the human user. Few companies use one provider for an end-to-end solution; instead there are often multiple providers for the different, and in some cases the same, aspects of regulatory operations, little standardisation, and vendors competing for new features to attract clients. Within the technical landscape, this makes standardisation a challenge. Systems and processes have evolved over many years but have not really been reviewed for their ongoing applicability, and certainly not on a widespread level.
This slow-moving technical landscape struggles to adapt to the exploding number of new legislations, rules and guidelines, and their increasing global complexity, bringing greater challenges for those submitting and reviewing applications. Nevertheless, there are basic standards available, driven, for example, by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or International Organisation for Standardisation (ISO), which can be considered first steps into the digital world. While the ICH eCTD [electronic Common Technical Document] standard reflects the paper-based approach, heavily relying on unstructured information, the proposed ISO IDMP [Identification of Medicinal Products] standard is already one step further ahead, providing structure to much of the data within a standardised model.
There are, however, some initiatives to improve the regulatory process for users. For example, the European Medicines Agency (EMA) was one of the first authorities to implement a rigorous and systematic Information Management Strategy in December 2015, with a view to harmonising data and definitions with controlled vocabularies. The strategy included master data standards that would allow seamless transmission between committees within an authority, as well as between regulators worldwide. As part of this, the EMA is implementing regulations developed by the ISO that cover the IDMP. It is expected that these standards will become the foundation of regulatory submissions not only in the EU, but also in the US and in further regions worldwide.
Despite all the enthusiasm for new digital solutions, the goal for any regulatory affairs efforts should not be forgotten: ensuring the approval of products that are safer and more effective than in the past. Digital transformation can be a trigger for innovative approaches, but at the end it can only be successful through dialogue and collaboration between industry, software vendors and regulators.
To date, within regulatory operations, digital solutions have evolved slowly. However, companies are starting to review and revise their technology landscape with increasing pace, for example by creating automated interfaces or introducing a master data management strategy; this enables different systems to start using the same vocabularies and applying the same standards. Advanced techniques providing significant opportunities include natural language processing (NLP) and robotic process automation (RPA). For example, information from certain documents, such as SmPCs [Summaries of Product Characteristics], but also quality documents (CTD Module 3), can be read and extracted by software and used for regulatory databases and further processing.
Furthermore, software can now screen regulatory authorities’ sites and alert users to changes in regulatory requirements. It is expected that more advanced systems can at least partly understand content and classify changes according to defined structures. Clearly, such regulatory intelligence allows companies to better meet regulators’ requirements and accelerate approvals, the rewards of which can be substantial.
When implementing new technology, it is important not to fall in to the trap of finding a solution looking for a problem; some challenges are best solved with existing technologies, while others rely on completely new approaches.
Digital systems that use NLP to understand, interpret and manipulate human language could ‘read’ the hundreds of thousands of pages of written information in a regulatory document. Already, automated systems can extract information from regulatory documents and classify – or even ‘understand’ to some extent – the data, and enter them into regulatory information management systems. Automated processes can also transfer information between systems to connect silos.
Insights can be offered from regulatory intelligence solutions, for example by analysing large, unstructured data sets across multiple health authorities and identifying changes in regulatory requirements using big data techniques, with NLP to bring added value. This can be supported by a regulatory intelligence platform that screens and categorises changing requirements, applying the results to the regulatory planning and submission process.
More sophisticated NLP – which can understand semantics – could support automated dossier compilation and hyperlinking, creation and maintenance of summary documents and prepare overview tables. Indeed, vendors are developing new ways to harmonise and automate document authoring, dossier publishing as well as the entire submission process.
Ultimately, digital transformation is about supporting people, optimising and enhancing processes and technology and finally influencing the way they work. This can be a trigger to rethink existing process and realign for greater efficiency, but this does not necessarily mean eliminating human input; rather, it is about allowing the experts to focus on the tasks that make the most of ‘human intelligence’. Inevitably, implementing new processes will always necessitate change management, with the associated challenges and opportunities.
R&D and pharmacovigilance are already embracing the use of innovative technologies, including artificial intelligence, to improve work practices. Adoption in regulatory affairs has been slower and there is a long way to go. Before any new technology is introduced, it must demonstrate a return on investment and in regulatory, unlike in drug development and safety, this can sometimes seem a challenge.
The need to share data for standardisation and advancement in regulatory process can conflict with the desire to protect commercial interests and this can exacerbate these challenges. With the harmonisation initiatives already underway between regulatory bodies, and the lack of any conflict of interest, this is a natural place for the application of technology to streamline the process, with many benefits for industry and regulators alike in working towards common standards.
Technology won’t revolutionise the regulatory industry overnight; there are too many challenges for this to be the case. Instead, small initiatives combining targeted use of digital solutions will show immediate value. Evolving in a stepwise manner, smart software solutions have the potential to facilitate higher quality and faster regulatory submissions, resulting in shorter time to market and allowing companies to realise the full clinical and commercial potential offered by their innovative medicines and devices.
Our experience in developing next-generation systems has shown that innovative technology can both drive efficiencies and support decision-making through enhanced regulatory intelligence. As companies push the boundaries of technology, those working in the pharmaceutical sector must embrace the opportunities it offers. In the regulatory environment, digital transformation will ultimately empower, but never replace, the human factor. While the regulatory environment is very much at the start of its adoption of smarter solutions, we look forward to seeing these advances introduced more widely to drive faster approvals, reduced costs and greater patient choice.
Timm Pauli is Senior Director, eSubmission Services, Head of Regulatory Operations, at PharmaLex.
He has more than 15 years of experience in pharmaceutical R&D.
He joined PharmaLex in 2014 and is responsible for all electronic submission activities, regulatory information management and related topics. He also consults on regulatory information management, IDMP-related topics and eCTD publishing systems.
Prior to PharmaLex, Timm worked at Merck Serono and Baxter Healthcare.
Rob Williams is Senior Director, Regulatory Informatics and Digital Technologies, at PharmaLex.
He has two decades of experience in the development of enterprise web-based solutions for global organisations.
He combines deep technical experience with business understanding and a client-focused approach. At PharmaLex he is responsible for driving the use innovative technologies to improve regulatory processes.