EMA Begins Setting Up New Bodies To Tackle Medical Product Shortages
April Workshop To Be Held To Explain Agency's Expanded Role
Executive Summary
A new EU regulation has come into effect that gives the European Medicines Agency wider powers to monitor, prevent and manage shortages of drugs and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.
You may also be interested in...
The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?
The EU Network and Information Security (NIS) Directive 2 entered into force this year, replacing the original NIS Directive. Cybersecurity is at the heart of NIS 2, and some of the new provisions are particularly important for the medtech and health sector.
MDR And IVDR – Similar Step Ups, Varying Commercial Impacts
Medtech Insight spoke to the CEOs of two companies that recently had very different experiences with the new European IVDR and MDR regulations to gauge their thoughts on any potential commercial impacts.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.