EMA Endorses Recommendations for Use of AI in Medicines Regulation

The European Medicines Agency (EMA) has endorsed the recommendations of the International Coalition of Medicines Regulatory Authorities (ICMRA) that address the regulatory oversight of artificial intelligence (AI) in medicines development. ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities.

AI includes various technologies, such as statistical models, algorithms and self-modifying systems, which are being applied across all stages of a medicine’s lifecycle from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimization. According to the EMA, this range of applications brings regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of AI failures and the wider impact these would have on AI uptake in medicine development and patients’ health.

The report, issued by ICMRA on August 6, 2021, identifies issues linked to the regulation of therapies using AI and makes specific recommendations for regulators and stakeholders involved in medicine development to foster the uptake of AI.

Main findings and key recommendations from the report are:

  • Risk-based approach. Regulators may need to apply a risk-based approach to assessing and regulating AI, which could be informed through exchange and collaboration in ICMRA.
  • Governance by bio/pharma companies. Sponsors, developers and bio/pharmaceutical companies should establish strengthened governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product; and
  • Areas for regulatory oversight. Regulatory guidelines for AI development, validation, and use with medicinal products should be developed in areas such as data provenance, reliability, transparency and understandability, pharmacovigilance, and real-world monitoring of patient functioning.

The report is based on a horizon-scanning exercise in AI, conducted by the ICMRA’s Informal Network for Innovation Working Group and led by EMA. The goal of this network is to identify challenging topics for medicine regulators, to explore the suitability of existing regulatory frameworks, and to develop recommendations to adapt regulatory systems in order to facilitate safe and timely access to innovative medicines.

The implementation of the recommendations will be discussed by ICMRA members in the coming months (as reported on August 16, 2021).

Source: European Medicines Agency

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