European Medicines Agency Revises Orphan Drugs Policy - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

European Medicines Agency Revises Orphan Drugs Policy


The European Medicines Agency has revised its policy on fee reductions for orphan drugs.  The changes provide enhanced fee reductions for companies that are not micro, small, or medium-sized enterprises (SMEs) and will take affect on January 1, 2014. The policy will continue to focus on assistance to SMEs with the objective of providing incentives to support research and innovation on medicines intended for the diagnosis, prevention, or treatment of rare diseases, as recommended by EMA’s Committee for Orphan Medicinal Products (COMP). Current fee-reduction rates will still apply to applications received by EMA until Dec. 31, 2013.
 
EMA has listed the following fee reductions for non-SMEs in 2014:

  • 75% fee reduction for non-pediatric-related initial and follow-up protocol assistance (currently a 40% fee reduction)
  • 100% fee waiver for pediatric-related initial and follow-up protocol assistance (no change from 2013)
  • 10% fee reduction for initial marketing-authorization applications (currently no fee reduction)
  • 100% fee reduction for pre-authorization inspections (currently no fee reduction).

The following services will remain free-of-charge for SMEs in 2014:

  • All initial and follow-up protocol assistance
  • Initial marketing-authorization applications
  • Pre-authorization inspections
  • Post-authorization applications and annual fees in the first year of marketing authorization.

Source: European Medicines Agency

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
28%
Attracting a skilled workforce
26%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
33%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here