Pink Sheet is part of the Business Intelligence Division 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 Pilot To Help Companies ‘Ease In’ To New EudraVigilance System

Executive Summary

The European Medicines Agency will use a phased approach to help companies comply with their obligation to monitor the revamped EU pharmacovigilance database and to report validated signals. Under a pilot to be launched on Feb. 22, 2018, companies will only have to monitor and report signals on drugs under additional monitoring.


Related Content

EU ADR Reporting Guidance Remains Complex, But Addresses Some Of Industry’s Concerns
EMA To Clarify Member State-Specific Requirements For New EudraVigilance System
Are You Ready? EU Launches Test Environment For New EudraVigilance System





Ask The Analyst

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

All set! This Question has been sent to 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