Reproduced from a webinar presentation, made in collaboration with TOPRA and Roche, given on December 15 by Caroline Kuhn, François Hebraud, and Vijay Reddi, of Roche.


Regulatory Rapporteur


January 2023   |   Volume 20   |   No.1


As regulatory professionals, we know first hand that we are working in a constantly evolving environment which develops in tandem with science, medicine and technology. Essentially, regulations, guidelines and processes evolve, and are influenced by the development of science and technologies combining more and more data, artificial intelligence, machine learning, precision medicine, genomic/ genetic analyses and devices which ultimately impact upon public health.

Furthermore, the Health Authority (HA) digitalisation strategy has had a major impact on regulatory affairs by transforming and optimising regulatory processes, for example, by integrating and modernising systems and processes for centralised procedures – eg., IRIS – and by replacing PDF-based forms to enhance structured data capture, such as DADI and the Webform AF.

Even if a product was originally approved in Notice to Applicant (NtA) format, today electronic Common Technical Document – eCTD – is required and the regulatory professional needs to be able to work with all the standards and digital platforms in order to maintain the medicinal drug licence. For products approved more than 20 years ago, it is possible to use real-world evidence from publications, even for off-label use and this could bring better insight in safety for some populations where recruitment may have been low, or, for example, not possible in the 1990’s.

The regulatory role therefore operates at the intersection between company needs and the external environment dynamic. Industry and society are interlinked and interwoven, for example the interplay between European and international markets, and consequently political, social, technological and health drivers.

The regulatory framework has a direct impact on the development and the lifecycle of a medicine. Having a voice to express the industry perspective on the functioning of the regulatory system, related challenges and opportunities is essential as a stakeholder. That is the role of regulatory policy. For example, the ongoing Revision of the EU general pharmaceuticals legislation – both Directive and Regulation, together with paediatric and orphan legislation – is a once in a lifetime opportunity to modernise the framework and ensure it is future-proofed.

This is an action resulting from the EC Pharmaceutical Strategy, published in November 2020. The EC adoption of related legal proposals is expected in Q1 of 2023 before being passed over to the co-decision bodies, the Council of the EU and the European Parliament, to start the ordinary legislative procedure. While not everything is addressed through the legislative pathways, it illustrates that the evolution of regulatory and legislative policy takes time and can span over many years. However, industry should not be complacent as the earlier that you engage with stakeholders, the more opportunities there are for shaping and influencing outcomes. (Figure 1).

Figure 1: Stakeholders’ engagement process in EC legislative process

Figure 1: Stakeholders’ engagement process in EC legislative process

Industry’s approach on policy should be through the cooperative development in the planning stages and a tactical approach to the process of legislation evaluation. This implies:

  • Identify an opportunity.
  • A problem statement and/or challenges.
  • Define the vision and goals to address external challenges and gaps.
  • Generate evidence to highlight the problem statement and showcase solutions (data, case studies and feedback etc).
  • Develop internal position.
  • Work with trade associations.
  • Map the landscape and identify and assess if stakeholders are aligned with the company position.

Following analysis, we should be in a position to know who the decision makers are, who and what influences them and last but not least engage externally.

The policy role suits individuals who can navigate and act in an unknown journey, while balancing and consolidating different interests. It requires, but also enables, regulatory professionals to expand one’s network both internally (with subject matter experts and a variety of functions such as public affairs, government affairs, communication) but also externally with other company representatives within trade associations and other stakeholders (EMA, NCA, HTA, patient organisation etc.)

The role facilitates broadening understanding of an evolving ecosystem and requires development of communication, influencing and negotiation competences both internally and externally. In general, across all specialisations of regulatory affairs – not solely regulatory policy – it is true to say that transferrable skills such as management and leadership are key to success in regulatory affairs.

Within regulatory affairs, and the industry, ideally we are aiming to work in an environment where we can make reliable decisions in real time, with no delays or complex systems to navigate. We should focus on what really matters and have a reduced timeline from the first submission to the last global approval.

And then work with integrated solutions and systems to provide insight from a trusted global information landscape and have a future workplace where the company, health authorities and the patient work together in an integrated ecosystem. Roche has established RAIL – Regulatory Approvals & Information Lifecycle – which encompasses strategy, execution, lifecycle management for all submissions across the different regulatory departments (including affiliates) and IT systems to transform how they deliver regulatory information in order to facilitate accelerated global approvals.

The patient is at the core of the RAIL strategy which focuses on both how we transform regulatory today and for the future. There are three distinct stages of the RAIL strategy, moving from foundational to transformational:

  • Critical enabling – delivering a single end to-end OneReg submission process, enabled by data and content reuse and automation, supported by an integrated tech ecosystem.
  • Real-time insights – enabling faster approvals determined by real time cumulative date from patients; accessible by all stakeholders.
  • Patient centricity – an integrated ecosystem between Roche, HAs and patients.

Data aspects have gained increasing significance over the past five years within regulatory affairs and one practical example of implementation of the RAIL labelling strategy and maturation model within Roche has encompassed a structured database that enables efficient information flow between several countries. This roadmap has moved from the current state of unstructured content to structured and reusable content, progressively moving to standardised and automated digital content and latterly as part of Roche’s Pharma Vision 2030 project to enable fully digital transformation.

Digital transformation is perceived as key to increasing efficiency and blend regulatory expertise and IT skills. For example, employing Robotic Process Automation for the automation of highly repetitive tasks, eg., publishing where time can be reduced from a number of days to minutes. However, it is important to recognise that pharmaceutical data is very different in nature and of increased complexity compared to other types of data – such as financial data – due to the high degree of variability between patients. In addition to leveraging IT and digitalisation technologies, it is also crucial to support individuals through the process of change and to help instil a positive and content mindset and behaviours to support these future ways of working.

The Pharma Vision 2030 digital transformation project will fully recognise the holistic nature of these developments and plot the synergies between the proposals on the roadmap in terms of the capabilities, the focus and the timescales. Once again, this complex web of projects demonstrates the continual evolution which our profession faces, and the need for regulatory affairs professionals to embrace, engage with, and be suitably briefed on, these changes.