Pink Sheet 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


EMA Explains How To Comply With Future EudraVigilance Reporting Requirements

This article was originally published in SRA

Executive Summary

The European Medicines Agency has issued a document explaining the changes that drug companies will need to make to their internal processes in the near future to allow them to carry out various pharmacovigilance-related tasks, such as reporting of drug side-effects and conducting signal management, when the EudraVigilance database is updated in 20171,2.

You may also be interested in...

New EudraVigilance System To Usher In Simplified Reporting of ADRs From Nov. 22

The European Medicines Agency is asking drug companies and EU national competent authorities to prepare for the late November launch of the new EU pharmacovigilance database, which will have enhanced functionalities for reporting and analysing suspected adverse reactions.

EMA Has Work Cut Out Before New Clinical Trial Portal Goes Live

Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.

EMA Explains Dos And Don’ts Of New Clinical Trials Portal

Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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