Agency Activity
This article was originally published in SRA
Executive Summary
European Medicines Agency highlights achievements in half-year report
European Medicines Agency highlights achievements in half-year report
The Management Board of the European Medicines Agency (EMEA) has adopted a communications technology strategy in order to implement pan-European IT systems and databases for collecting and disseminating information on medicines in the European Union (EU). This was one of the key announcements at the board's 4 October meeting, where the agency's executive director, Thomas Lönngren, presented a half-year report1.
The EU telematics master plan is expected to provide a development strategy, between 2007 and 2013, for several IT projects relating to pharmacovigilance, clinical trials, authorised medicinal products and manufacturing and marketing authorisations2. The board noted that one of the major achievements during the first half of 2007 was the successful roll-out of a new data analysis system for EudraVigilance, which is one of main components of the EU telematics master plan, to all competent authorities in EU member states. EudraVigilance is a European, web-based information system that is designed to handle safety report information in full compliance with International Conference on Harmonisation (ICH) specifications. Further information on the subject can be found on the EMEA website (www.emea.europa.eu)3. [In a recent article appearing in the BMJ medical journal, two Italian pharmacologists have noted that the system is “still far from being fully implemented”4. - Ed.]
The meeting also included the presentation of the second status report on the implementation of the EMEA Road Map to 2010 project. The project aims to put into effect several initiatives to expand and strengthen (among other things) the network between regulatory authorities in the EU, and strengthen the EMEA's international regulation with non-EU regulatory authorities5. The status report highlights progress made in 2006 and the first half of 2007 in areas that include improving the safety of medicines, stimulating research and innovation in partnership with European institutions, improving availability to medicines, strengthening the provision of information and interaction with agency stakeholders, reinforcing international collaboration and strengthening the European regulatory system for medicines. A new action plan is also currently under preparation, which will set out the initiatives to be undertaken in 2008 and 2009. The first status report, covering the progress made to the end of 2005, is available on the EMEA website6.
Marketing authorisations
The half-year report also indicated a strong level of applications for marketing authorisations that have been submitted to the EMEA, the agency said. By mid-2007, the agency had received a total of 42 applications, with a further 52 applications forecast by the end of the year. This follows the record number of applications made to the agency in 2006. The area of biosimilars has grown significantly, with eight applications being made in the first half of 2007, and a further eight are expected by the end of the year.
Paediatrics
The board also highlighted as a major achievement of the first half of 2007, the implementation of the new paediatric regulation and the establishment of the Paediatric Committee (PDCO). The PDCO is responsible for processing paediatric investigational plans (PIPs), ie drug-development plans for obtaining paediatric indications, or requests for waivers. The PDCO reported in September that it had received applications corresponding to 105 PIPs or requests for waivers, and is currently reviewing submissions relating to indications in areas of oncology, ophthalmology, infectious diseases, endocrinology, immunology, neurology, cardiovascular diseases and pneumology7.
References
1. EMEA press release, 12 October 2007, http://emea.europa.eu/pdfs/general/manage/mbpr/45493507en.pdf
2. EMEA website, accessed 19 October 2007, www.emea.europa.eu/htms/general/direct/legislation/eutelematics.htm
3. EudraVigilance website, 22 October 2007, http://eudravigilance.emea.europa.eu/human/index.asp
4. Garattini S and Bertelè V, How can we regulate medicines better?, British Medical Journal, 20 October 2007, 335, 803
5. EMEA document, 4 March 2005, http://emea.europa.eu/pdfs/general/direct/directory/3416303enexec.pdf
6. Road Map status report, 10 May 2006, http://emea.europa.eu/pdfs/general/direct/directory/17132106en.pdf
7. PDCO press release, 1 October 2007, http://emea.europa.eu/pdfs/human/pdco/44069407en.pdf