Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.| European Medicines Agency (EMA)
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedureand serves as a collection of terms, and their definitions. This guideline applies to new or revised analytical procedures used for release and stabilit...| European Medicines Agency (EMA)
Rybelsus is available as tablets to be taken by mouth once a day and can only be obtained with a prescription. Patients should start on the lowest dose, which is increased to a maintenance dose after one month. After at least one month on this dose, the dose can be increased to the next higher dose if needed.| European Medicines Agency (EMA)
EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.| European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines.| European Medicines Agency (EMA)
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These medicines are used for weight loss and for treating type 2 diabetes.| European Medicines Agency (EMA)
