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: Revision of Annex 6 - Manufacture of Medicinal Gases

EMA: Revision of Annex 6 - Manufacture of Medicinal Gases

EMA and PIC/S have published a concept paper announcing a targeted revision of Annex 6 Manufacture of Medicinal Gases of the EU GMP Guide. The last update dates from 2010. The revision aims to reflect current manufacturing practice, technological progress and lessons learned from the COVID-19 pandemic.

Read more
EMA: Concept Paper on the Revision of Annex 15

EMA: Concept Paper on the Revision of Annex 15

EMA and PIC/S have published a concept paper outlining a targeted revision of Annex 15 (Qualification and Validation).

Read more
What do Typical Manufacturing Processes for Sterile Products look like?

What do Typical Manufacturing Processes for Sterile Products look like?

Here's the answer:
Read more
Human Resource Management as a Key to Success

Human Resource Management as a Key to Success

The pharmaceutical industry in Germany and other countries, too, faces considerable challenges in the area of human resource management. These problems have far-reaching implications for the competitiveness and innovative power of the industry.

Read more
EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

The EMA has published a new reflection paper outlining its current thinking on the qualification of non-mutagenic impurities (NMIs). The paper addresses recommended approaches for evaluating the safety of new or increased impurity levels, particularly when such impurities exceed the ICH Q3A/Q3B qualification thresholds and are identified after completion of non-clinical toxicology studies.

Read more
EMA: Discussions on the Revised ERA Guideline

EMA: Discussions on the Revised ERA Guideline

During the second industry stakeholder webinar on the revised guideline on environmental risk assessment (ERA) for medicinal products for human use, the European Medicines Agency (EMA) addressed key implementation challenges observed during the first year of application.
Read more
Previous
Next