Draft EMA Reflection Paper on Artificial Intelligence

EMA Publishes a Draft Reflection Paper on Artificial Intelligence (AI), which is Now Open for Public Consultation

On 19th July 2023, the European Medicines Agency (EMA) published a new draft reflection paper on the use of Artificial Intelligence (AI) and machine learning (ML) throughout the lifecycle of both human and veterinary medicines.

The paper, which was co-developed by the Big Data Steering Group, the Committee for Medicinal Products for Human Use (CHMP), and the Committee for Veterinary Medicinal Products (CVMP), reflects on the scientific principles of AI that require regulatory evaluation, when these emerging technologies are applied to support the safe and effective use of medicines.

The draft paper outlines the EMA’s current thinking and experience on the use of AI/ML and provides considerations on its application throughout a product’s lifecycle, from initial drug discovery and development, through the regulatory evaluation process, as well as in post-authorisation settings, such as pharmacovigilance and the performance of effectiveness studies.

Whilst the reflection paper acknowledges the growing importance and promise of AI in data acquisition, transformation, analysis, interpretation and decision making, it recognises the need to mitigate new risks and avoid the integration of bias into any AI system, to ensure the safety of patients and the integrity of any clinical findings, as well as to maintain trust in the use of AI for this purpose.

Whilst currently established regulatory principles for data management, governance, statistical stringency etc. may remain directly applicable to the use of AI/ML, organisations will be required to ensure that data science competence is fully integrated in the development process for medicines. The reflection paper concludes that a human-centric approach should guide all development and deployment of AI/ML, and the use of these technologies should always occur in compliance with the existing legal requirements, considering ethics and ensuring due respect for all fundamental rights.

The public consultation is now open and EMA are inviting all interested partners, developers, academics, and other key stakeholders to comment on the draft reflection paper, and to identify the anticipated benefits and risks of the use of AI within the field of medicine.

If you wish to provide feedback, this can be done by completing a dedicated form; the deadline for comments is 31st December 2023.

Of note, before the close of the consultation period, the EMA and Heads of Medicines Agency (HMA) plan to hold a joint AI workshop from 20th – 21st November 2023.

Following on from the previous 2021 workshop, in which stakeholder’s priority AI-related topics were established, this meeting will allow the EMA/HMA to provide updates on the delivery of these priorities, as well as to hold discussions on the draft AI reflection paper, and deliver presentations on AI developments in technology and policy, and its potential application in the regulation of medicines.

Registration for this workshop is expected to open in September 2023.

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Draft Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation on a rapidly evolving world