The EMA recently published its annual report for 2009.
General comments on the year’s performance highlight the effort and resource devoted by the Agency to addressing the problems posed by the H1N1 pandemic. The Agency makes reference to the fast-track review of pandemic vaccines – and the close monitoring of these vaccines once they were being used to vaccinate millions of European citizens – and it cites these as demonstrating to Europe and to the world that the European medicines network can deliver high-quality scientific assessments even under enormous pressure.
More specifically, in the areas of Compliance and Inspections the report notes that there were 175 GMP inspections carried out on behalf of EMA, some 35 below the expected number of 210. There were also two joint GMP inspections carried out with FDA. It is reported that 80 quality defects were handled in 2009 (slightly fewer than the previous year).
In the field of international co-operation in the Compliance and Inspection area, significant progress is reported in 2009. The Agency took the lead in an initiative from the third summit of International Heads of Medicines Agencies to strengthen the approach to supervise active substances and supply chains in collaboration with other international partners including the US, Canada, Australia and the WHO. Work in this area continues.
The report highlights the new accessibility to the public of information on manufacturing authorisations and GMP certificates in the EudraGMP database.
The report makes interesting reading and is a valuable insight to the breadth of work carried out by the Agency.