The European Medicines Agency (“EMA”) has released on 18 December 2023 a comprehensive workplan on Artificial Intelligence (AI) that outlines a variety of initiatives to be undertaken from 2023 to 2028. According to the EMA, the objective is to develop a collaborative strategy that optimises the advantages of AI while mitigating the potential risks associated with its implementation.

In consideration of the ramifications of AI in various sectors of healthcare, the EMA has concentrated its efforts on four dimensions that ought to aid in the responsible development and application of AI. However, the EMA emphasises that future modifications to the proposed workplan may be necessary in response to advancements in this technology. The EMA workplan consists of four key dimensions: i) Guidance, policy and product support, ii) Tools & technologies, iii) Collaboration and change management, and iv) Experimentation.

The first key dimension “Guidance, policy and product support” aims to support the development of AI throughout the life cycle of pharmaceuticals. Thereby, it is anticipated that orientations and guidance in areas such as pharmacovigilance and the application of complex language models will be approved. In addition, establishment of an observatory to oversee the implementation of the AI Law and preparations for its implementation are anticipated to commence in the latter part of 2024.

Regarding the second key dimension “Tools and technology”, there are several planned objectives for the year 2024. These objectives encompass assuring adherence to data protection regulations, establishing guidelines to facilitate communication via generative AI, and integrating language models as assistants. A survey and the publication of a policy regarding the functionalities of network tools are also anticipated.

In the third key dimension “Collaboration and change management” it is anticipated that collaboration on the comprehension and implementation of AI will be strengthened in 2024 through the establishment of an AI Special Interest Area, collaboration with international partners specialising in AI, and the development of an expanded platform for the Digital Academy on AI and data analytics, among other initiatives.

Finally, in the key dimension “Experimentation” anticipates that from 2024 to 2027, numerous cycles of experimentation may occur, under the guidance of technical deep investigations. Additionally, governing principles for the responsible application of AI are to be established.

By implementing this strategic plan, the EMA makes a significant stride towards incorporating AI into its processes and the entire life cycle of pharmaceuticals. This development will unquestionably reach a turning point in the realm of data collection and potentially health-related decision-making.