EMA mid-year report highlights surge in GMP inspections
There were 350 inspections in January to June 2015, compared with 235 in the same period of 2014
The number of good manufacturing practice (GMP) inspections undertaken by the European Medicines Agency (EMA) surged in the first half of 2015, according to the Agency's Mid-year report 2015.
There were 350 inspections compared with 235 in the same period of 2014, and the number of probes almost exceeded projected caseloads for the whole of the year.
Meanwhile, the report indicated that efforts to encourage small-and-medium sized pharma companies to use EMA services are bearing fruit, with 34% of requests for scientific advice coming from such businesses in January-June 2015. Overall, there was a year-on-year 6% increase in such requests from all sources over this timescale.
There was also a higher than expected number of protocol assistance requests, although this – suggested the report – could be related to applications for funding from the EU’s Horizon 2020 research programme, which launched last year.
Regarding initial evaluation applications, the report said there had been a fall in numbers, which were below expectations – although there had been an anticipated increase in new orphan medicinal product applications.
There was also a steep fall in pharmacovigilance referrals, down to three, from 12 in the same period in 2014 and 25 in 2013.
The report, however, highlighted efforts to celebrate the Agency’s 20th anniversary, and 50 years of EU pharmaceutical legislation. It noted that a pilot project on gathering data on scientific advice and protocol assistance had been scheduled to wind up in September, with findings to be released later.