Europe’s 3 obstacles

Europe is aware of that potential artificial intelligence (AI) In the development and life of drugs. An example of this is that last December, the European Medicines Agency (EMA, for its acronym in English) published an action plan to guide its use in the regulation of these products. However, the application of the tool brings with it numerous challenges Which the living being has to face.

EMA has found that three issues pose challenges to the application of this device. These are summarized Understanding Algorithmsrisks of technical failures and the “broad” effect of the device.

“AI and machine learning have the potential to effectively support Data acquisition, transformation, analysis and interpretation Throughout the life cycle of the drug. However, this range of applications brings with it a number of challenges,” explains EMA Medical writing.

These challenges focus first Understanding AlgorithmsEspecially its design and possible prejudices, We continue to focus on the risks of technical failures And finally, it will have a “broad” impact on the adoption of AI in drug development and patient health.

To shed light on this issue, the EMA and the heads of medicine agencies (HMATo provide ideas, guidance and support to regulators and other interested actors in the use of AI.

For example, Europe recently launched an action plan to guide the use of AI in medicines regulation, which is valid until 2028. To do this, they have relied on four dimensions: guidance, policies and product support; Equipment and Technology of AI; support and training and ultimately, Use,

Each dimension has established objectives and deadlines. The first of them will provide ongoing support Development and evolution of AI In the life cycle of drugs; The second is to identify and provide a network-wide framework for using tools to increase efficiency, improve understanding and data analysis.

In form of Support and TrainingInitiatives have been taken to continuously develop the capacity of the network. Finally, in Use Testing cycles will be conducted whose maximum duration will be six months.

AI to boost drug development

But not only in this regard is the documentation published about this device. On behalf of the EMA, a draft of a reflection document on AI to support the development, regulation and safe and effective use in human and veterinary medicines was presented in July. Once the brief, whose public consultation concluded in late December, is finalized, guidance on AI will be provided “based on input from interested parties,” the regulatory agency explains.

“The document highlights that a human-centered approach Should guide all development and deployment of AI and machine learning. The use of AI in medicine and the life cycle must always be in accordance with current legal requirements, guaranteeing due respect for fundamental rights and considering responsible ethics, the EMA reminds.

Therefore, in situations where artificial intelligence or machine learning is used to design, develop and monitor medicines, the EMA gives “advice” to the developers prompt regulatory supportThat is, through innovative products, development methods or the ability to provide scientific advice.