The European medicines agency has just published the report on its activities during 2012, rare diseases, small and medium-sized enterprises and pets growing sectors in terms of applications for new products. A useful document for understanding in which direction pharmaceutical research is moving, which sectors will be most affected by the introduction of new drugs and which strategies the agency is pursuing to protect public health. Compared to previous years, the requests for new registrations for medicinal products for human use have been stable, in 2012 there were 96. The CHMP (Committee for medicinal products for human use) has issued 59 favorable opinions for new drugs, including the first gene therapy. Overall, the agency reports an increase in the complexity of the dossiers received: requests for orphan medicines grew by 36% compared to 2011, indicating widespread interest in rare diseases and approval of the incentive policy envisaged for these categories of medicines. In fact, the EMA designated 107 specialties as orphans in 2011, 148 in 2012 and estimates that there will be more than 150 in 2013. It should also be underlined that the 72% of orphan drugs is aimed at the treatment of children's diseases. Another significant trend is that relating to drugs for veterinary use: in 2012, the agency received 12 applications for new products, of which only one out of 4 concerned farm animals while the remaining 75% was for pets. A decisive trend reversal compared to 2011 when the two categories were on a par with one 50% each. Great attention was also paid to antibiotic resistance: in fact, the agency released, upon request, 9 scientific opinions on products containing antimicrobials intended for farm animals, to ensure that the appropriate conditions of use were specified in the authorisations.
April 19, 2013 – DoctorNews33
