EMA’s consultation on the draft Regulatory Science to 2025’ strategy, covering the future vision for both human and veterinary medicinal products, is open up to 30 June 2019. The consultation is based on contents of a Reflection paper from the European Medicines Agency; the online module to forward comments to the European Medicines Agency is available at this link. The results from the consultation will support the final drafting of the new EU Medicines Agencies Network Strategy (2020–2025).

Flexibility to integrate innovation in science and technology

A more flexible regulatory system, able to sustain innovation in both areas of activities of EMA (human and veterinary) should be the final objective according to the Agency’s general director Guido Rasi, who asked stakeholders their opinion if the current proposal is “sufficiently ambitious”.
Key elements included in the draft strategy have been identified in collaboration with the European Commission and National Competent Authorities. Recent advancements in science and technologies have been the focus of attention, as they pose many challenges to be faced in order to integrate them and improve activities in the pharmaceutical development field.
New emerging models for the future of pharma business are increasingly based on emerging technologies, big data and precision medicine. These models require a better integration between science and technology and the availability of new competencies for their management, as well as the availability of innovative technologies used in production or the evolving design of clinical studies. The same challenge is posed also to regulators, as they are called to identify emerging trends and produce new guidelines to support the industry in the implementation and use of innovation.
The new paradigm of precision medicine is based on the identification of sub-groups of patients more prone to respond to a certain therapeutic intervention. It makes use of a wide stratification of patients through the increasing amount of available biomarkers and the many “omic” technologies. Advanced therapies are another area of great attention for the future of EMA, as well as innovative therapeutics and regulatory procedures to support a timely and rapid access for patients to new medicines. Nanotechnologies and new materials are becoming more and more important in the development of new products, a dynamic that should be reflected also by a better comprehension of their features and possible issues from a regulatory point of view.

Regulatory advice should be provided in an integrated way along the continuum of the development process, according to EMA’s vision. The complexity of many new treatments also requires a more integrated approach for the evaluation of the medicinal product itself and the medical device associated with it. An integration which also extends to in-vitro diagnostics and borderline products.
The explosion of real world data shall also change deeply the way clinical studies will be run in future years, together with the increasing availability of collaborative evidences, and it should be reflected by the new regulatory strategy. Non clinical models based of the 3R principle (Reduce, Replace, Refine) shall also be useful to achieve this objective. Data modelling, extrapolation and simulation, also supported by the emergence of artificial intelligence and other digital technologies, might help expanding the evaluation of data in order to better assess the benefit-risk ratio. This should be also the goal for an improved communication to the population by mean of special initiatives.

A better access for patients

Another priority set by EMA for the future of the regulatory sciences is the improvement of patients’ access to new and innovative treatments. An action that requires a strict collaboration with the national healthcare systems. Regulators are called to improve the health technology assessment (HTA) procedures in order to smooth the path for downstream decisions. In this case too, the optimisation of the process is directly linked to the availability of high quality real world data and to a better involvement of patients in the generation of the needed evidence. Big data and artificial intelligence are once again crucial, requiring specific competences, collaborations and improvements in the area of electronic product information (ePI). According to EMA, patient knowledge should be ameliorated also by promoting the availability and use of biosimilars and a greater trust in the European regulatory system.

How to face emerging threats

Health emergencies and threats are another point of great attention for the future, according to the proposed EMA’s strategy. A new plan to face the emerging threats and emergencies and protect the European population should be put in place, and further research is needed in order to make available new antibacterial products, or alternatives useful to fight antimicrobial resistance. The theme of the shortage of medicines remains a hot topic that would require a stronger collaboration at the global level to be proactively faced.
Other issues to be afforded in the incoming years include, according to EMA’s document, the development, approval and post-market monitoring of new vaccines, and the creation of a reference framework for the repurposing of already approved medicinal products for new indications.
A network of partnerships among regulators, the academy and experts in regulatory sciences working together at research activities on strategic areas would also help to achieve the many ambitious goals set forth by EMA’s vision and to early identify the new, emerging questions looking for answers by regulators. The network should also represent an opportunity to improve access to the best European and internationally available expertise, and a mean to diffuse regulatory knowledge, experience and innovation.

The future vision for the veterinary area

Many of the above mentioned objectives are valid also in the veterinary area of EMA’s activities, especially with respect to the integration of science and emerging technologies to support product development. A suggestion from EMA would see the updating to most recent advances of science of the modalities to run the Environmental Risk Assessments and the evaluation of the safety of residues of veterinary medicines.
Veterinary pharmaco-epidemiologic and pharmacovigilance standards would also need to be updated, an effort that would require an improved collaboration among stakeholders. This might benefit from the creation of new models for the communication among involved parties and new approaches to assess the benefit-risk ratio for veterinary products.
Here again, the fight against antimicrobial resistance needs to support the responsible use of antibiotics in animals, a coordinated collection of data on such usage and a better involvement of stakeholders to minimise risks to develop resistance. The development of veterinary vaccines is another priority of EMA’s vision for the future.

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