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

EU Orphan Law A 'Remarkable Success' But Approval Speed and Patient Access Still Poor

This article was originally published in SRA

Executive Summary

While the 15-year old EU orphan drugs legislation has "significantly helped to accelerate the translation of science into therapies for patients with rare diseases", orphan drugs are still not being approved - or reaching the patients who need them- fast enough.

You may also be interested in...



Changes To EU Orphan Similarity Concept Could Change Innovation Threshold For 10-Year Exclusivity

The European Commission has proposed changes to the existing criteria used for determining whether a new medicinal product is similar to an already authorized orphan drug and, therefore, whether it can be accepted for evaluation and granted 10-year market exclusivity.

COVID-19 Vaccine Dosing: Pharma Says Follow The Science As It Gathers Data

The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.

India Permits Sale Of Some Devices Beyond Licensing Deadline

Existing importers and manufacturers of certain medical devices can continue marketing their products for six months or until the Indian medtech regulator makes a final decision on their pending licensing applications.

UsernamePublicRestriction

Register

OM006051

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