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

Long-Awaited EU Review Questions 10-Year Orphan Exclusivity

Prevalence Criterion Also Under The Spotlight

Executive Summary

The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."

You may also be interested in...



EU Seeks Suggestions On How To Improve Pediatric & Orphan Drugs Legislation

Companies wanting to get involved in long-running plans to overhaul the EU orphan drugs and pediatric medicine legislation can make their contribution through a public consultation that began on 10 May.

EU Orphan And Pediatric Proposals Insufficient, Says Industry

Innovators warn against slashing incentives and argue a lack of a common definition of unmet need is a stumbling block to proposals.

How To Get Orphan Drug Status In Great Britain From 2021

Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period.

Related Content

Topics

UsernamePublicRestriction

Register

PS142719

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

Cancel