EMA's Mid-Year Report Merits Scrutiny

A mid-year summary of the European Medicines Agency's 2012 activities underlines the growing trend toward closer collaboration between international regulators.

EMA has appointed a new FDA liaison officer, based at the FDA, and this move is part of the overall plan to promote EMA-FDA interaction on specific issues. Both agencies acknowledge the importance of starting dialogue early in the development process and promoting a high level of informal interactions between EMA and FDA and exchanges on ongoing applications. EMA has also appointed a new Japanese liaison official.

Guido Rasi is the EMA's Executive Director.

"The agency provided support to the European Commission for collaboration with Russia on GCP," noted the authors of the report. "As part of the pilot program for the parallel assessment between EMA and US FDA of quality by design aspects in marketing applications, a parallel evaluation in a first submission has been completed. Harmonization of lists of questions has been undertaken."

On a less positive note, however, the report reveals that public access to clinical trial results is delayed, pending the launch of the database. Moreover, the discharge by the European Parliament for the EMA's 2010 budget has been delayed. The Parliament requested improvements in a number of areas, particularly in managing conflicts of interest. EMA has now published declarations of interests, and the CVs of all managers have been included in the European expert database. EMA expects the issue to be resolved by the fourth quarter of 2012.

"Our main performance indicators have been met. The mid-year report indicates that the agency is on target to meet its core business objectives for 2012," Executive Director Guido Rasi told the EMA's Management Board on October 4. Among the other highlights in the report were:

• The number of new marketing authorization applications for new human medicines received so far is largely in line with 2011 figures for the same period (52). But the forecast for applications to be submitted by the end of the year has fallen from 112 to 101, owing mainly to a lower than expected rate of submission of applications for generic products for human use.

• Requests for scientific advice and protocol assistance for new human medicines rose by almost 14% and 24% respectively compared to figures from the same period in 2011. This confirms the growing importance of early regulatory advice on development programs, according to EMA.

• There was a significant increase in the number of applications for orphan designation (30% above the same period in 2011). About 63% of the orphan medicinal products fund had been used (€3.79 million of €6 million). Overall, EMA's budget for this year is 222.5 million euros, of which 71% (€158.1 million) had been committed by the end of the first half of the year.

• The plan to move the Agency to new premises (Project 2014) is progressing in line with expectations.

• The number of face-to-face meetings involving EMA staff continues to fall. There were 221 such meetings in the first half of 2012, compared with 287 in the same period of 2011, and 316 in the same period of 2010. The number of virtual meetings is growing, however.

• EMA currently has 559 temporary agents, 113.5 contract agents, and 93 other staff (national experts, interims, trainees).

• For clinical and non-clinical compliance, EMA received 42 GCP inspection requests, of which eight were pharmacovigilance inspections. No good laboratory practice inspection requests were received. In April, the agency published a reflection paper on GCP and ethical aspects of clinical trials conducted outside of the European Union.

• A successful link was made between the EU Clinical Trials Register information and the World Health Organization's International Clinical Trial Registry Platform.

Implementation of the new pharmacovigilance legislation is progressing as planned, according to the report. EudraVigilance aggregated data for centrally authorized medicines for human use was published on May 31, 2012. Since the Management Board's last meeting in June 2012, the Pharmacovigilance Risk Assessment Committee has been established and met three times. The board has pledged to continue to monitor the implementation of the legislation carefully.

—Philip Ward