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The European Medicines Agency: Regulatory Science to 2025

Paper Type: Free Essay Subject: Sciences
Wordcount: 2303 words Published: 8th Feb 2020

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Because of the unprecedented acceleration of science, technology and information associated with the development of medicinal products, and to future-proof enhanced public health, regulatory agencies must now catalyse and enable innovation to be translated into patient-centred healthcare.  To achieve this objective, medicines regulators have to assume a new role, therefore, at the intersection between novel scientific discovery, product development and patient access to new, safe, effective and high-quality medicines.

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The regulation of medicines in the European Economic Area is coordinated by the European Medicines Agency (EMA) working together with the European Medicines Regulatory Network (EMRN, the ‘network’) of national competent authorities in the Member States.  The EMA and the EMRN are responsible for providing citizens of the European Union (EU) with effective, safe, and high-quality medicines, as well as a regulatory environment that facilitates the development of new medicines to promote and protect human health.

The path that translates discoveries in fundamental biomedical science into improved clinical practice demands rigorous procedures to evaluate the safety, efficacy and quality of potential new therapies and diagnostic tools.  The role of “regulatory science”[1] in this context, therefore, is to produce the basic knowledge and understanding essential for robust regulatory decision-making.  In this way, regulators are equipped to apply cutting-edge technological tools and the most recent scientific advances to enable the objective assessment of the benefits and risks of new medicinal products.

Hence, the focus of regulatory science research is the generation of information to guide regulatory decisions related to medicinal products with the potential to improve human health.  Examples of the incredible spectrum of transformational research that are having a significant impact on the regulatory science agenda include cell-based therapies, genomics-based diagnostics, drug-device combinations, novel clinical trial design, predictive toxicology, real-world evidence, and the impact of ‘big data’ and artificial intelligence.

Clearly, therefore, the challenging scientific questions for regulators are evolving from the most active and competitive areas of biomedical science and, even though the eventual focus must be on clinical relevance, an effective assessment of a new medicinal product demands information from validated technologies and methods based on fundamental knowledge and understanding.  As a result, the potential impact on human health of regulatory science research is extremely high as this is the conduit by which innovation reaches and transforms clinical practice.

In summary, then, it is critically important that advances in regulatory science match those in basic and applied science and technology. In this way, EMA and the network can offer informed guidance on modern product development, facilitate the optimisation of regulatory tools to improve the process, and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

Consequently, in September 2016, the EMA created a Regulatory Science Observatory to monitor and sign-post emerging and future trends in science and technology, and to direct the use of resource and external collaborations to strategically advance regulatory science. The specific ambition was to identify key priorities where new or enhanced engagement is essential to the continued success of the Agency’s mission (namely, to catalyse and enable science to be translated into patient-centred care and its delivery in evolving healthcare systems[2]) and hence to shape and influence the vision for the EU Medicines Agencies Network Strategy in the period 2020–25.

To fulfil this objective, the key trends in science, technology and regulatory tools impacting EMA operations were surveyed in-depth and the results, and their interpretation, were supplemented with an extensive series of outreach activities with stakeholders at all levels of the medicine development pathway (including regulatory science experts, European research infrastructure networks, scientific associations, academia, healthcare professionals, patient representatives, big and small pharma/biotech, and health technology assessors and payers).  The culmination of this collective effort was a workshop held at EMA in October, 2018, “EMA – Regulatory Science to 2025” [1], at which five strategic goals were outlined (Figure 1):

Figure1.  EMA – Regulatory Science to 2025; strategic goals.

1. Catalysing the integration of science and technology in medicines development

The aim is to ensure that regulation can support the development of new and innovative medicines and techniques, so that patients’ needs can be better addressed with safe, effective and clinically appropriate treatments. This requires the network to address, for example, moves to more patient-centred healthcare, and precision, or personalised, medicine and to acknowledge advances taking place in the development of ‘omics, biomarkers, medical devices, in vitro diagnostics and borderline products, as well as novel approaches to medicines manufacturing; in short, to see the latest scientific and technological knowledge built into medicines development. This requires closer collaboration with academics, research centres and infrastructures and ensuring that this is embedded into the ongoing dialogue between regulators and developers at all stages of the lifecycle including, in particular, the scientific advice process.

2. Driving collaborative evidence generation – improving the scientific quality of evaluations

The goal is to provide regulators with better evidence to underpin regulatory decisions, so that patients can gain timely access to innovative treatments while continuing to be protected from medicines whose benefits do not outweigh their risks. This is particularly true in paediatric populations, rare orphan conditions and conditions of high individual and public health burden. Underlying much of this is the increasing incorporation of new digital tools into medicines manufacturing, development and clinical care protocols. This means that data could be more widely and efficiently collected throughout the lifecycle of a medicine, from preclinical development, through the clinical trial process, and into real world use. Improved evidence generation also offers a chance to capture patient preferences better during the evaluation process and make clinical development and regulation more cost-effective, potentially reducing the burden on healthcare systems.  Specific areas meriting particular focus include new non-clinical models, innovative clinical trial design, the rich datasets captured by ‘wearable’ and other technologies, and the use of modelling, simulation and extrapolation.

3. Advancing patient-centred access to medicines in partnership with healthcare systems

Acknowledging that patients and healthcare professionals are at the centre of the regulatory system’s actions, this strategic objective is to advance access to medicines and ensure (a) that patients receive timely access to affordable, high-quality medicines, which they need, and (b) that all the players involved in healthcare have the information necessary to guide correct prescription and use.  The EMA must therefore build on its existing frameworks that bring together stakeholders at all levels of the decision-making chain, including, importantly, patients and healthcare professionals themselves. Cooperation is also essential to ensure that real-world data, or more broadly ‘big data’, meet the needs of all stakeholders including health technology assessors and payers and can be used in the service of this goal.  Beyond data use, capitalising on the success of biosimilars will further advance access. Additionally, to ensure that patients can make informed decisions about the medicines to which they have access, improved communication, such as moves towards the delivery of electronic product information for patients and healthcare professionals, is required.

4. Addressing emerging health threats and availability/therapeutic challenges

In recognising that the EMA’s mission is to protect human health, this goal is directed at ensuring that the regulatory system can respond effectively to address the need for treatments of emerging health threats, and the availability of medicines for existing ones.  EMA must therefore continue its commitment and preparedness planning to support global efforts to respond to existing and emerging public health threats, and its support for the development of new antimicrobials and ways of managing resistance. It must also support innovative approaches to developing and monitoring the safety of vaccines, and initiatives to improve communication and build public understanding and trust.  Another area to be addressed is the unavailability of medicines in the EU, either because they are not developed or marketed, or due to supply disruptions. As unavailability can have many causes and is a global issue, response to such challenges requires cooperation at different levels, involving multiple stakeholders and international partners. One way to tackle unavailability and unmet medical needs is to explore whether established medicines, licensed for particular conditions, can be used in other conditions. This has the potential to reduce the time and expense of development and offer additional therapeutic options to patients.  Availability of less expensive medicines may also be facilitated via validation of in vitro and/or in silico tools to demonstrate bioequivalence of generic products to the reference-listed standard.

5. Enabling and leveraging research and innovation in regulatory science

The final objective is to further develop the existing interaction between the EU network and academia to be kept informed of relevant scientific innovations and research and to identify solutions to regulatory needs and challenges. This is the key to delivering the other strategic goals and recommendations laid out above.  It is specifically envisaged that this aim can be achieved by establishing a novel regulatory science and innovation platform in partnership with academic research centres (a) to provide a mechanism for scientists in the regulatory network and academia to collaborate in identifying and tackling fundamental research questions of high relevance, (b) to allow network scientists and academia to collaborate and address, in a timely way, emerging innovations that require new regulatory competencies, methods, or tools, and (c) to access expertise in regulatory science system to better track innovation and enable enhanced insight into the development of novel medicinal products. The ultimate outcome of this approach is to ensure that regulatory science remains at the cutting-edge such that EMA can deliver its fundamental mission of protecting human health and facilitating the availability of medicines to patients.

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Each of these strategic goals is underpinned by a number of core recommendations, which serve as specific objectives to be targeted over the next 5-10 years.  It is envisaged that the core recommendations will be realised by series of planned underlying actions which identify explicitly the practical steps to be undertaken (see Supplementary Information).  A draft document, “Regulatory Science to 2025” presents in detail the outline presented here and has now been published for consultation [2] during the first half of 2019.  Following consideration of the feedback received, a final version of the document will be released and presented at a workshop in the fourth quarter of 2019.  Interested stakeholders are strongly encouraged to read the consultation document and to provide comments on the strategy proposed.


[1] https://www.ema.europa.eu/en/events/multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science

[2] Link to public consultation document.

[1]A useful working definition of regulatory science is “the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences, and contributes to the development of regulatory standards and tools.”

[2] G. Rasi, “EU’s Innovative Medical Technology and EMA’s Measures”, presentation at the Summit of Heads of Medicines Regulatory Agencies Symposium and International Coalition of Medicines Regulatory Authorities (ICMRA) meeting, Kyoto, Japan, October 27, 2017;  https://www.pmda.go.jp/files/000220949.pdf


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