GQ-201 as minor use or minor species product classified [ 10 Oct 2013 ]
GeneQuine received a positive decision by EMA's Committee for Medicinal Products for Veterinary Use (CVMP) on classification of GeneQuine's lead candidate GQ-201 as product for minor use or minor species (MUMS).
MUMS status for veterinary drug candidates is comparable to orphan drug status for human products. The MUMS policy is intended to stimulate development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be developed in the current market conditions.
EMA's policy and procedures to assist applicants with submitting applications should help companies to bring MUMS products on the market and, thus, to meet the current unmet medical need and improve animal welfare.
Based on the MUMS status, reduced data requirements for quality, safety and efficacy apply for GQ-201. GeneQuine can furthermore benefit from the Agency's administrative assistance and advice, which covers all aspects of applications from scientific advice to marketing authorization application. The MUMS status will enable GeneQuine to pursue the most time and cost efficient product development and regulatory strategy for GQ-201 towards marketing authorization.