Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Australian Pharma Warns Against Removing Orphan Fee Incentives

This article was originally published in PharmAsia News

Executive Summary

Australia's pharmaceutical industry association, Medicines Australia, has objected to proposals by the Therapeutic Goods Administration to eliminate fee waivers for the registration and evaluation of orphan drugs. The association warns that if this incentive is removed, "local sponsors may not invest in bringing these products to market in Australia as this would not be commercially viable in many instances".

You may also be interested in...



Simplified Clinical Trial Transparency Rules To Go Live In The EU In June

A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules. 

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency

The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC089105

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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