Interest shown by the pharmaceutical industry in the first year of the European Medicines Agency’s initiative to help smaller firms in the sector has exceeded expectations, the Agency has reported.

The initiative - which seeks to help micro, small and medium-sized enterprises (SMEs) in the drug sector to innovate and develop new products - began on December 15, 2005, when the EMEA launched its new SME Office to provide them with incentives such as financial and administrative assistance, fee reductions, deferrals and exemptions, and help with translations.

In December 2006, the Agency reported that 136 companies had so far sought assistance through the scheme. Of those, 108 had been assigned SME status by the EMEA, while applications from 25 firms were under review, two had been withdrawn and one had expired. The large majority of companies in the scheme are developing medicinal products for human use, while three are veterinary companies and three are regulatory consultants, it adds.

The Agency defines “micro” enterprises as those employing less than 10 staff and with an annual turnover or balance sheet total not exceeding 2 million euros. “Small” enterprises have fewer than 50 employees and an annual turnover or balance sheet total of no more than 10 million euros, while “medium” enterprises employ less than 250 staff and make annual sales of not more than 50 million euros, or have an annual balance sheet total of no more than 43 million euros.

Access to the incentives is the same, regardless of whether a company is classified as micro, small or medium.

24% of companies which have been assigned SME status so far are micro-enterprises, a percentage which the agency describes as “substantial” and “very encouraging.” Many of these firms are start-up companies originating out of university research projects. Medium-sized firms account for 39% of the total and small companies for 37%.

Attention from Europe

The initiative has attracted attention throughout Europe, the Agency adds, with firms from a total of 17 countries expressing interest so far. Most companies assigned SME status to date are based in the UK, with 24, followed by France (16), Germany (13), Denmark (10), Sweden (9) and Belgium (8).

Looking at the SME Office’s activities in its first year of operation, the Agency says it has provided regulatory assistance to 14 companies. In eight cases, meetings or teleconferences were organised. It has provided assistance on a wide variety of topics, including: general regulatory strategy for obtaining a Marketing Authorization; eligibility for EMEA procedures; applications for orphan designation; and by responding to detailed queries from companies in the run-up to the filing of an MA Application.

SME status entitles firms to a 90% reduction in fees for scientific advice from the EMEA and, in the first year, 23 firms took advance of this. Forty percent of these sought advice on all areas of development (quality, non-clinical and clinical), while 30% asked for both non-clinical and clinical advice and another 30% wanted help in just one area. To date, a total of 1.4 million euros in SME fee reductions has been processed for scientific advice under the scheme, and companies will be encouraged to seek follow-up advice as their product developments proceed, says the Agency.

Eight MAAs filed

Eight SME companies submitted MAAs during the year, seven of which are for human-use drugs (and one for a veterinary product). Of these seven, six are designated orphan medicinal products and one is now under fast-track review. Payment of fees totalling 1 million euros for MAAs and inspections have been deferred by SMEs using these incentives so far.

Looking to the future, the EMEA reports that a procedure for providing SMEs with translations of product information within the scope of a centralised MAA is currently under development, and also that the first draft of a detailed User Guide to the scheme is currently with the European Commission for agreement. The draft will be published on the EMEA website for a three-month consultation period.

In addition, the first SME training workshop, entitled Navigating the Regulatory Maze, will tale place in February. Registration for the workshop has now closed but information on the presentation will be published on the EMEA web site, along with details of future workshops.

For further information, and for a list of companies currently participating in the scheme, visit: smeoffice@emea.europa.eu