Faster medicines to patients through regulatory reliance

Beyond the ICH, the strategic direction of regulatory harmonisation is supported by several other trans-national collaboration institutions and platforms, for example the International Medical Device Regulators Forum (IMDRF), and the World Health Organisation (WHO). 

Efforts towards regulatory reliance also align with broader societal goals of efficiency and sustainability. By reducing the need for every country to conduct full regulatory reviews on its own, reliance initiatives contribute to streamlined workflows and optimised use of human resources within regulatory agencies allowing a focus on national specifics. This, in turn, enables a more agile response to emerging healthcare challenges, supports long-term sustainability of global health systems, and accelerated access for patients.

Pharmaceutical companies must comply with global standards for development and manufacturing, as well as with all quality, safety, and efficacy aspects throughout the product life cycle of medicines and diagnostics. Marketing authorisations are only one component, an important one, in the life cycle of a medicine. Diverse, additional, country-specific requirements are also asked for by many countries across a product’s lifetime. A lack of common standards adds additional layers of complexity, leading to many different versions of a dossier being developed to secure authorisation for the same product in different countries, with lengthier  timelines as a result. At Roche we support the harmonisation of scientific and technical standards and convergence of procedures to allow for a single dossier. This would avoid unnecessary duplication of regulatory effort across different geographies and help accelerate new treatments to patients everywhere.

As the regulatory landscape evolves, Roche has been and continues with an openness to  piloting new approaches and has participated in a number of projects that bring valuable insights into how reliance can drive positive outcomes across diverse regions and health systems.

One of Roche’s most impactful initiatives has been supporting regulatory reliance across Africa. Working within regional reliance frameworks, Roche has for many years supported harmonisation and reliance initiatives that have strengthened national and regional regulatory systems, for example ZaZiBoNa in southern Africa or the East African Community Medicines Regulatory Harmonisation program. Today, most African countries participate in subregional joint assessment procedures, which allow for a unified review process based on shared reliance practices. And we look forward to the establishment of the continental regulatory body, the  African Medicines Agency (AMA), that will pool resources across the continent and ensure also that complex innovative and biotherapeutic products are adequately assessed and available to patients there through the continental reliance framework that is under development

In addition, the ACCESS Consortium, comprising Australia, Canada, Singapore, Switzerland, and, more recently, the UK, provides a powerful showcase of the potential of collaborative regulatory frameworks. Initially established to speed up generic drug approvals, ACCESS has expanded to include biosimilars and innovative medicines. By relying on each other’s regulatory work, the consortium countries avoid duplication of efforts, variable approval timelines and accelerate patients’ access to treatments. ACCESS has enabled Roche to file marketing applications in multiple countries simultaneously, underscoring the value of this collaborative model.

In oncology, the pilot project ORBIS, led by the FDA, has allowed partner countries such as Australia, Canada, and Singapore to benefit from the FDA openness to sharing its reviews. This work-sharing model helps gain time in the approval of critical cancer therapies. Roche, for example, has filed several supplemental marketing applications and new molecular entities under Project ORBIS.

Roche has also blazed a trail in a pilot5 that shows the extensive potential of reliance, in this case, in securing approval for major post authorisation process changes to one of our oncology medicines. The pilot shows reliance in action and supports its efficient implementation globally. The regulatory approval of the process changes was accelerated by almost 2 years, i.e. from a non-reliance timeline of 2.5 years to 6 months. It was achieved by leveraging the EMA as reference agency and using a single dossier (i.e. as for EMA). In all, 48 health authorities from around the world agreed to participate in the pilot which was also supported by the WHO. The outcome has been truly impressive, showing what is possible when using reliance, and inspiring others to similar pilots, which will in turn drive broader implementation of reliance pathways.

The COVID-19 pandemic unambiguously illustrated the power of regulatory cooperation in crisis response. Behind-the-scenes coordination and information sharing among regulators facilitated rapid approvals of vaccines and treatments, setting a precedent for future collaborative efforts during health emergencies like SARS, avian flu, and more recently, monkeypox. Such crises bring into sharp relief the critical need for streamlined regulatory pathways that can swiftly adapt to evolving public health needs.

In the post-pandemic era, the regulatory assessments for evaluating new medicines and diagnostics are increasingly being shared among WHO-listed Authorities. Further harmonisation and reliance on decisions made by other trusted authorities has strong potential to enhance efficiency, align timelines for accessing new innovations across regions, as well as lowering related costs across the medicine’s life cycle. There are a lot of efforts underway on a global and regional level with the objective of seeing increasing regulatory convergence especially for complex, innovative cell and gene therapies.6 Such therapies are novel, and the scientific expertise required for their assessment, in short supply.

The advent of digital technologies holds immense potential to amplify the benefits of regulatory reliance. Platforms like Accumulus7 and DEEP8 hold the promise of enabling real-time data sharing, collaborative reviews, and dynamic knowledge management across borders. Cloud solutions and modern digital knowledge management systems can now support and enable scaling of phased reviews and ultimately of dynamic assessment. These innovations have the potential to not only facilitate faster decision-making processes but also support continuous monitoring and post-market adverse events’ surveillance, ensuring ongoing safety and efficacy of approved products. Such regulatory productivity can better support delivery of public health and on common issues such as global supply shortages.  

Given shortages of scientific expertise, all major agencies are encouraged to consider scientific work sharing activities based on trust and reliance. The EMA’s international work assessment collaboration is crucial to advancement of science in global clinical developments in the future. However, certain stakeholders argue  towards a blending of the scientific remit of EMA with the economically focused remit of HTA bodies and payers which would add to the complexity and cost of pharmaceutical development and challenge global regulatory collaboration and harmonisation efforts. Likewise, and distinct from medicines regulation, is the necessity to keep reliance pathways for medical devices and in vitro diagnostics separate, and define regulatory pathways that consider the unique nature of these products.