Skip to main content Skip to search Skip to main navigation

US, Canada, and UK issue joint principles on Good Machine Learning Practice

The US FDA, Health Canada, and the British regulatory agency MHRA have jointly released 10 guiding principles to support the development of Good Machine Learning Practice (GMLP). As a basic framework it should help to promote safe, effective, and high-quality medical devices, while using AI (artificial intelligence) and ML (machine learning).

Being considered a rapidly progressing field, the principles should be used to:

  • Adopt good practices that have been proven in other sectors
  • Tailor practices from other sectors so they are applicable to medical technology and the health care sector
  • Create new practices specific for medical technology and the health care sector

The 10 principles read as follows:

 

All details to the guiding principles set out by the three agencies can be found here. Any feedback is welcome through the public docket at Regulations.gov.


Source:

FDA: Good Machine Learning Practice for Medical Device Development: Guiding Principles

 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

What Types of Impurities may be Present in Active Substances?

What Types of Impurities may be Present in Active Substances?


Read more
There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry

There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry

In pharmaceutical manufacturing, clean air is not a subjective perception but a precisely controlled technical condition that is essential for product safety. Heating, ventilation and air-conditioning (HVAC) systems ensure, through airflow management, air filtration and pressure control, that particles and microorganisms are kept away from critical areas. This is based on clearly defined requirements for air changes, cleanliness classes, airflow patterns and pressure concepts, all of which are designed according to the manufacturing process and contamination risk involved.
Read more
EU: Analysis Supporting the Proposed Biotech Act

EU: Analysis Supporting the Proposed Biotech Act

The European Commission has published the analysis underpinning the proposed Biotech Act. The initiative aims to strengthen Europe’s biotechnology and biomanufacturing sectors and to accelerate the development, production and market uptake of biotechnology-based innovations.
Read more
EFPIA: Results of the Member Survey 2025 on GMP and GDP Inspections

EFPIA: Results of the Member Survey 2025 on GMP and GDP Inspections

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published the results of its “Annual Regulatory GMP/GDP Inspection Survey 2025”. The data suggest that international GMP inspections are increasingly being replaced by reliance and work-sharing approaches between inspectorates.
Read more
What are the Core Tasks of Human Resource Management?

What are the Core Tasks of Human Resource Management?

Here's the answer:
Read more
European GMP Regulations: Ongoing Changes and What Lies Ahead

European GMP Regulations: Ongoing Changes and What Lies Ahead

At the 2026 ISPE European Annual Conference in Copenhagen, Brendan Cuddy (EMA) provided a concise update on current European GMP regulatory developments and the work of the GMP/GDP Inspectors Working Group (GMDP IWG).
Read more
Previous
Next