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

UsernamePublicRestriction
UsernamePublicRestriction

EMA To Clarify Member State-Specific Requirements For New EudraVigilance System

Executive Summary

Drug makers preparing for the launch of the enhanced EudraVigilance database in the EU will soon be told about any plans, arrangements and requirements that are specific to the national competent authorities.

You may also be interested in...



EMA Pilot To Help Companies ‘Ease In’ To New EudraVigilance System

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.

Italy Opens Up ADR Database To The Public

The Italian regulatory body AIFA has announced a new system allowing the public and health professionals access to information held on the national database of adverse drug reactions. The database can be searched by brand name or active ingredient.

EMA Suspends Some Activities & Warns That High Job Losses Could Halt Its Operations

Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU. The EMA is also concerned that unexpectedly high staff losses will seriously affect its ability to operate.

Topics

UsernamePublicRestriction

Register

MT142464

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

Cancel