European Medicines Agency Changes Procedures for Orphan Drug Fees - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

European Medicines Agency Changes Procedures for Orphan Drug Fees


The European Medicines Agency (EMA) has stopped requiring sponsors of orphan drugs to inform EMA of their intention to submit an application to be eligible for a fee reduction. This change is part of EMA’s effort to streamline the procedures for fee reductions and is effective immediately.

Drugs that have been granted orphan designation by the European Commission on the recommendation of the EMA’s Committee for Orphan Medicinal Products are eligible for fee reductions for a range of regulatory activities including pre-authorization activities such as protocol assistance, the application for marketing authorization, and inspections. EMA will no longer require additional information from the sponsor before submitting an application eligible for fee reduction for orphan drugs.
EMA has removed “Procedural Advice on Fee Reductions for Designated Orphan Medicinal Products” from the Agency’s website and the standard operating procedure on processing of fee reductions for designated orphan drug products (SOP/H/3048) is now obsolete.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here