The EMA has released its final report of its activities in 2015. The report highlights the key achievements, the current state of the initiatives introduced by them as well as the key figures that marked the previous year. The report informs that 56.9% of the products that received a positive opinion at the Committee of Orphan Medicinal Products were nervous system products.
According to the report the 258 orphan designations were given in 2015, which was below than 2014, but higher than the previous years. Among the marketing authorizations provided, about 71% of the orphan medications would cater to the pediatric population as well.
The report highlights its collaborations with the United Stated and Japanese regulatory authorities as where in “one in three applications for orphan designation was submitted to EMA and to another regulatory authority in parallel in 2015.”
They held a record of 163 pre-submission meetings to advise applicants on their request for orphan designation.
The support of the European Commission development of medicines for rare diseases was valuable as they provided 6.5 million Euros in 2015 to the EMA for assisting in the various steps to marketing authorization of these medicinal products.
While there was an increase in the number of requests for advanced therapy medicinal product (ATMP) classification in 2015 compared to 2014 (61 versus 28), it should be noted that more than one in five applications were for orphan designated medicines – one was for an ATMP.
The report also includes important statistics on the evaluation process as well as information on the involvement of experts, patients and healthcare professionals in scientific assessments.