"It can take up to thirteen years for a patented drug to enter the market."
An expert from the European Medicines Agency explained at the University of Navarra how they centralize the procedures to authorize its commercialization.
PHOTO: Courtesy
According to Ana Zanoletty, an expert at the European Medicines Agency (EMA), "it can take up to thirteen years for a patented drug to enter the market". This was stated at her lecture within the Master's Degree at research, development and Medicines Innovation (MIDI) of the School of Pharmacy of the University of Navarra.
Zanoletty, a former student at the academic center, explained how the EMA centralizes the procedures for authorizing the marketing of drugs. Through six phases (pre-application, first assessment, review, second assessment, decision and post-authorization), the agency offers member countries guidelines for presentation of their applications, scientific advice and reports from assessment, in addition to monitoring and surveillance of authorized drugs, among other services.
Standardizing access to medicines in the European UnionThe EMA is the European Union agency in charge of protecting and promoting public and animal health, through the assessment and supervision of medicinal products for human and veterinary use. To this end, through the centralized procedure , it is in charge of scientifically evaluating the application for authorization to market medicines, submitted by the member countries. The goal, according to Zanoletty, is "that there should be a single pharmaceutical market in the European Union to standardize access to new and better drugs for any member of the Union".