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

UsernamePublicRestriction
UsernamePublicRestriction

EFPIA Picks Holes With EMA's Revised Guidance On Risk Management Plans

This article was originally published in SRA

Executive Summary

The European Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help remove "several redundancies present in the current version" of the guidance. However, EFPIA has significant concerns over certain other parts of the revised guideline, such as the rewording of certain sections that it believes could be misinterpreted by those enforcing the guideline and create confusion.

Advertisement

Related Content

EMA Revises Guidance On Risk Management Plans To Address Industry ‘Misunderstandings’
EU Drug Safety Actions Speeded Up By New Legislation, Says Commission

Topics

Advertisement
UsernamePublicRestriction

Register

PS118706

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

Cancel