EMA revises its polices on fee reductions for orphan drugs for 2014.
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:
The following services will remain free-of-charge for SMEs in 2014:
Source: European Medicines Agency
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.