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:

EMA: Scientific Guideline on Development and Manufacture of Synthetic Peptides

EMA: Scientific Guideline on Development and Manufacture of Synthetic Peptides

The EMA has published the final version of the scientific guideline „Development and manufacture of synthetic peptides“.
Read more
EU: Strengthening Pharmaceutical Supply Chains and Global Health Resilience

EU: Strengthening Pharmaceutical Supply Chains and Global Health Resilience

The European Commission has published a new communication on reinforcing global health resilience, with a strong focus on resilient pharmaceutical supply chains, expanded manufacturing capacity, and security of supply for critical health products.
Read more
Annex 22: EMA Workshop on AI in GMP

Annex 22: EMA Workshop on AI in GMP

The European Medicines Agency (EMA) will hold a two-day multistakeholder workshop on 30 June and 1 July 2026 to gather expert input for the development of Annex 22 of the EU GMP Guide on the use of artificial intelligence (AI) in medicines manufacturing.
Read more
FDA: Pilot Program for One-Day Inspectional Assessments

FDA: Pilot Program for One-Day Inspectional Assessments

Since April 2026, the U.S. FDA has been piloting “One-Day Inspectional Assessments” as a complement to standard FDA inspections.
Read more
EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 further specifies requirements for notified bodies under the MDR and IVDR frameworks and aims to promote a more harmonised implementation across the European Union.
Read more
What is the Importance of Data Integrity?

What is the Importance of Data Integrity?

Here's the answer:
Read more
Previous
Next