The European Medicines Agency (EMEA) managed to speed up its assessment times in 2006, despite reviewing more new drugs than in any other year.
In its first full year of operation under the European Union’s revised pharmaceutical legislation, the EMEA received a total of 78 initial approval applications (involving 69 active substances) for human-use medicines, plus one application for a drug intended exclusively for use outside the EU. This was considerably more than the 62 applications forecast for the year and almost double the 41 submitted in 2005. Of last year’s tally, 18 of the applications were for orphan medicinal products, nine for generics/hybrids and three for biosimilars.
At the same time, the agency’s annual report for 2006 shows marked reductions in the various phases of the centralised approval procedure. For drugs that secured a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the average time in the assessment phase dropped to 171 days from 203 days in 2005. The EMEA post-opinion phase – which incorporates agency processing and the time required by applicants and the EU member states to carry out post-opinion translation checks – was down from 56 to 36 days, while the decision process took an average of 31 days compared with 41 in 2005.
On top of this came a slight improvement in the ‘clock-stop’ time required by companies applying for marketing authorisations. This took up 164 days on average in 2005 and 161 days in 2006.
Turnaround times for orphan drugs cut
The EMEA also cut the turnaround times for its orphan designation and scientific advice procedures. The agency received 104 applications for orphan designation in 2006, 14 fewer than in the previous year. But the average time for an opinion on orphan designation fell from 60 days in 2005 to 57 last year, the fastest turnaround since the procedure started in 2000. The average time to a decision in the orphan-designation procedure was down from 50 to 25 days.
The provision of scientific advice to companies on their drug development programmes benefited from the implementation of a new operational framework implemented from 1 July 2006. This included appointing four additional members to the Scientific Advice Working Party and extending its meetings to three days; streamlining the procedure to allow finalisation within 40 to 70 days; and involving co-ordinators and their assessors/experts systematically in the planning/pre-submission phase.
The number of requests for scientific advice and follow-up continued to climb sharply, from 136 in 2005 to 201 in 2006. Nonetheless, the mean duration of these procedures was 73.4 days in the assessment phase last year, against 79 days in 2005; the mean time for validation stayed level at 14 days. In all, the EMEA finalised 257 scientific-advice, protocol-assistance (for orphan drug sponsors) and follow-up requests in 2006, up from with 191 in the previous year.
The EMEA is expecting the volume of requests for scientific advice to increase by 25% this year, largely as a result of the EU’s new regulation on paediatric medicines. In 2006, 55% of the requests concerned drugs in clinical development, while 28% related to the preclinical phase and 17% to quality issues. Within the clinical development spectrum, 63% of requests for scientific advice were about Phase III trials, 20% were Phase II requests, 15% Phase I and 2% Phase IV.
