Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Medtech Guidance Tracker - December 2015

This article was originally published in SRA

Executive Summary

You may also be interested in...



EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans

An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.

EMA To Get The Ball Rolling On Making CTIS Global

The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.

EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data

While the International Council of Harmonisation is developing a harmonized approach to patient-focused drug development, the European Medicines Agency has heeded calls for “prompt guidance” to support the systematic inclusion of patient experience data in regulatory submissions.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT040684

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