Kent Woods wants stakeholders to know he understands: 2011 was a tough year.
As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst of a crisis of confidence.
The good news, says Woods in the forward to a new Management Committee report on EMA's 2011 activities, is the agency is in a better place after a tumultuous year. "It has been a year of significant challenges, but also one of substantial progress towards improving public health through the regulation of medicines," wrote Woods.
In addition to a transition in leadership, EMA has been grappling with what Woods calls "major pieces of European legislation": new pharmacovigilance legislation, the impending launch of the Clinical Trials Directive and the adoption of the Falsified Medicines Directive. The agency also forged stronger ties with US regulators in the hopes of deploying resources more efficiently and consistently.
Rasi seemed to agree with Woods' sentiments, saying it was indeed "a challenging year," but the agency has shown itself to be "capable of overcoming major challenges," including France's Mediator case, a budget held up over conflict of interest policies, reports Lönngren joined a consulting business while still acting as Executive Director and more.
Despite making a number of advances to remedy these issues, including new conflict of interest transparency guidelines, the report explains EMA will experience a number of issues going forward.
"[The] agency is currently in a phase of zero growth and due to economic pressures across the entire EU regulatory network, a number of aspirations in the 'Road map to 2015' cannot be addressed with the current resources available," wrote EMA. Like the US Food and Drug Administration (FDA), EMA has been increasingly reliant in recent years on user fees paid by industry to finance its operations. Since 2005, the percentage of its operations paid for by EU general contributions has dropped from 25% in to just below 14% in 2011. Success, emphasizes the report, is contingent upon finding ways to save resources, re-engineer processes, deliver efficiencies and demonstrate best practices.
In the midst of this potential shortage of resources, EMA says it is receiving more applications for initial evaluations of human medicines this year than in the past two years. 2011 saw 100 initial medical product applications, while 2010 and 2009 saw 91 and 96, respectively. 2011 also saw three applications for biosimilar products, up from just one in both prior years.
Generic medicine applications were one of the few areas to fall substantially, going from 48 applications in 2009, to 43 applications in 2010 and 34 applications in 2011.
Another area to see a marked decline in applications was paediatric and paediatric investigation plans (PIP), both of which fell sharply compared to 2009 and 2010. 2011 saw just 187 PIP applications and 220 clinical indications in the same PIP applications. 2010 had 326 and 403, respectively, while 2009 had 273 and 364. EMA said much of the fall was due to a record-high surge in PIP applications in the years prior for allergen products coming onto the German market.
When grouped by product type, blood products, neurology/CNS products, sensory organ products and musculoskeletal products appeared to have the most difficulty receiving EMA approval. Just 17 out of 26 musculoskeletal products received positive opinions from EMA in 2011. Conversely, products intending to treat alimentary tract ailments received 17 positive opinions for 17 products.
Overall, EMA approved 87 products in 2011, offered four negative opinions and saw 13 products removed for consideration prior to an opinion. This overall trend was up from 2010's 51 approved products, but was less than 2009's 117 approved products.
The overall approval process also appeared to take substantially longer in 2011 than in both 2009 and 2010. The total time to product approval in 2009, including company stop-clock days was 346 days. In 2010, that number rose to 360 days. In 2011, EMA took a total of 392 days-an increase of 8.1% over 2010.
EMA also moved to aggressively increase the number of manufacturing inspections the agency is conducting. Inspections related to good manufacturing practices (GMPs) increased 39% between 2010 and 2011, while good clinical practice, pharmacovigilance and good laboratory practice inspections stayed largely the same.
Quality defects reported to the agency also saw a large increase in between 2010 and 2011, increasing 39% while overall recalls decreased slightly (4%).
EMA - Annual Report 2011