Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EMA Finalizes Quality Requirements For Drug-Device Combinations

Executive Summary

New EU guidance discusses the quality documentation needed for medicines that contain a device component for their delivery or use.

You may also be interested in...



Global Medtech Guidance Tracker: July 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.

No Shocks Expected In EU Quality Guidance For Drug-Device Combinations

Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.

EMA To Coordinate GMP Inspections Via Online Portal

The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.

Topics

UsernamePublicRestriction

Register

MT144265

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel