Pink Sheet 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


EMA Takes Steps To Improve Predictability Of Drug Submissions

Executive Summary

The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”

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.

Swissmedic Asks Sponsors For At Least Four Months’ Notice Ahead Of New Drug Filings

Companies looking to file medicines containing new active substances in Switzerland should notify the regulator up to six months before their planned submission date to support early planning activities, Swissmedic says.

EMA To Get Tough On Companies That Repeatedly Delay New Marketing Applications

Disappointed that its earlier initiative to improve the predictability of planned marketing authorization applications has failed to have an impact, the European Medicines Agency is discussing introducing more active measures as passive ones are not working.


Latest Headlines
See All



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