Suppose a DHT is used in the context of drug product development, evaluation, or monitoring and is expected to impact, even potentially, on the benefit-risk assessment of a Marketing Authorisation Application (MAA). In that case, relevant aspects of the technology will be discussed at the time of MAA evaluation. A qualification, or another form of regulatory input such as scientific advice, should be considered by the applicant during the product development. A Q&A document may provide helpful considerations for the preparation of the submission documents to EMA.
EMA Regulatory Science to 2025 enounces five strategic goals for regulatory science. EMA seeks to help regulatory science develop and use it to ensure advances in knowledge translation in a timely way into new, safe, and effective treatments for patients. The vision for human medicines is to underpin its mission of protecting human health, and EMA must catalyze and enable regulatory science and innovation to translate into patient access in evolving healthcare systems. To this end, five strategic goals are proposed. Each is associated with a set of core recommendations and their supporting actions.
1: Catalysing the integration of science and technology in medicines development
2: Driving collaborative evidence generation — improving the scientific quality of evaluations
3: Advancing patient-centered access to medicines in partnership with healthcare systems
4: Addressing emerging health threats and availability/ therapeutic challenges
5: Enabling and leveraging research and innovation in regulatory science
The report HMA-EMA Joint Big Data Taskforce is an overarching summary of the reports of the six subgroups with recommendations that set out some common steps along the road to regulatory acceptability of big data. The recommendations start with data standardization to define and, where possible, improve data quality and progress to actions to promote data sharing, access, and enable robust Big Data processing and analysis. These steps are not necessarily sequential, are often interdependent, and will be iteratively requiring a constant engagement with external stakeholders to articulate regulatory needs as the field further develops. Additionally, across all big data domains, there is a need to ensure the European regulatory network develops and maintains sufficient expertise to guide, interpret and critically assess big data.
The willingness of regulatory authorities to consider real‐world evidence (RWE) for regulatory decision‐making when there is an unmet medical need, is described in the case of studies for BAVENCIO (avelumab), BLINCYTO (blinatumomab), and INVEGA SUSTENNA (paliperidone palmitate) in Trial designs using real‐world data: The changing landscape of the regulatory approval process.
Fundamental guidelines for DHT are NICE, UK Digital Health Innovation Action Plan, FDA, and Communication, enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society (link), EU, and WHO. Classification of digital Health Interventions.
