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Small- and medium-sized enterprises (SME) play a major role in the development of new medicines for patients, said the European Medicines Agency (EMA) in a report on Wednesday.
The EMA summarized its experience with SMEs over the past ten years in the report, emphasizing the importance of SMEs in pharmaceutical innovation.
SME applications for the marketing authorization of new medicines account for approximately 10 to 15 percent of the overall number of applications, said the report.
By the end of 2015, 1,619 companies from across the EU were registered as SMEs with EMA.
Moreover, SMEs are highly important in addressing rare diseases, as 42 percent of the medicines recommended for marketing authorization in the past ten years were orphan medicines, drugs which are developed for rare diseases.
The success rate of SMEs in the market approval process for human medicines has also improved over the years, growing from 68 percent from 2010 to 2012, to 75 percent in 2015.
In addition, SMEs are increasingly benefiting from scientific advice during the development of human medicines.
A total of 158 of the 473 requests for scientific advice finalized by EMA in 2015 came from SMEs, 30 percent more than in 2014, said the report.
For veterinary medicines, the number of requests for scientific advice has also increased over the last ten years.
As for human medicines, there is also a focus on smaller markets for SMEs. One in four medicines that were recommended for marketing authorization were for a limited market, said the report.
(APD)
