EMEA forecasts 12% rise in drug filings in 2008

The European Medicines Agency (EMEA) offered 65 drug marketing opinions in 2007, and predicts in its annual report that its workload is set to increase substantially this year.

EMEA offered 58 positive opinions and seven negative opinions, 14 more than in 2006, while there were nine application withdrawals last year.

Its workload for novel human drugs, scientific advice and post-authorisation variations was higher than in any other previous year and "a greater number of positive opinions were adopted", it said. The ratio of positive to negative opinions was roughly similar to previous years.

Cancer medicines were the most represented therapeutic category, followed by anti-infectives and alimentary-tract medicines.

Last year EMEA received 90 drug filings - 12 more than in 2006 - including 11 applications for orphan medicines, 10 for generics and 10 for biosimilar medicines. In addition, one application was made for a scientific opinion on a medicinal product intended for use outside the EU as part of EU efforts to support developing countries.

Furthermore, application numbers for initial marketing authorisations, post-authorisation variations and requests for scientific advice relating to medicines for human use were all higher in 2007 than in any previous year.

According to EMEA's work programme for this year, the volume of activity in 2008 is expected to surpass the reported figures for 2007. It forecasts a 12% rise in filing numbers this year to 102 applications.

"Changes in the scientific and regulatory environment stemming from the further implementation of the new pharmaceutical legislation will shape the EMEA's priorities for 2008," said the report.

Strong growth is also forecast in the number of requests for scientific advice for human medicines, with more than 360 requests expected.

Other highlights of 2007 included:

• 281 scientific-advice requests relating to the development of medicines for human use were received - 22 more than in 2006.
• 125 orphan-designation applications - 21 more than in 2006, and the fourth year in a row that applications for rare disease status exceeded 100.
• 10 opinions were adopted by the Paediatric Committee: two on paediatric investigation plans and eight on full waivers for research in all subsets of the paediatric population.
• Two positive opinions on initial marketing authorisations for vaccines against avian influenza in poultry were adopted, following an accelerated evaluation procedure.

EMEA said considerable efforts were made in 2007 to strengthen the proactive approach to safety of medicines. "Major progress on establishing an intensive drug monitoring system was achieved through the delivery of the EudraVigilance Datawarehouse and Analysis System, which supports signal-detection and the assessment of adverse drug reaction reports, and the identification of centres across the EU as the first phase in the launch of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

"Efforts to reinforce a proactive approach to the monitoring of the safety of medicines will remain high on the Agency's agenda, including initiatives to be undertaken in the context of the European Risk Management Strategy (notably the ENCePP project), the further development of EudraVigilance databases, and the improvement of the concept of risk-management plans for human medicines," it added.