The International Coalition of Medicines Regulators (ICMRA), in a published report, has outlined recommendations to help regulators address the challenges posed by the use of artificial intelligence (AI) for global drug regulation.

AI includes various technologies (such as statistical models, various algorithms and self-modifying systems) that are increasingly used at all stages of the drug life cycle: from preclinical development, registration and analysis of clinical trial data to pharmacovigilance and optimization of clinical use. This range of applications poses regulatory challenges, including the transparency of algorithms and their implications, as well as the risks of AI disruptions and the wider impact they will have on AI in drug development and patient health. Medicines (EMA).

The report identifies key issues related to regulating future AI therapies and provides specific recommendations for regulators and stakeholders involved in drug development to foster AI adoption.

Some of the main findings and recommendations:

• regulators may need a risk-based approach to assess and regulate AI, which can be based on information sharing and collaboration through ICMRA;
• sponsors, developers, and pharmaceutical companies should establish strengthened governance structures to oversee algorithms and AI adoption that are closely related to the benefit / risk of the drug;
• it is necessary to develop regulatory recommendations for the development, validation and use of AI in medicines in such areas as data validation, reliability, transparency and understandability,
  pharmacovigilance and monitoring of patient functioning in the real world.

The report is based on a study of the prospects for the development of AI, conducted by the informal working group ICMRA "Informal Network" led by EMA. The purpose of this framework is to identify challenging topics for drug regulators, examine the suitability of existing regulatory frameworks, and develop recommendations for adapting regulatory systems to facilitate safe and timely access to innovative medicines.

Implementation of the recommendations will be discussed by ICMRA members in the coming months.

Source: https://pharmprom.ru/