Biotechs flock to EMEA’s SME office

Europe’s small biotechs have leapt to take advantage of the European Medicines Agency’s (EMEA) office for SMEs, according to a review of its first year in operation. The office was launched on 15 December 2005 to make it easier for SMEs to get marketing approval for new drugs.

Up to 1,500 companies are eligible to use the service, which offers a 90 per cent reduction in fees for scientific advice and inspections. Fees for administrative services have been abolished and payments for marketing authorisation applications are deferred until the end of the evaluation process and fees are waived for SMEs that have requested and followed EMEA's scientific advice but do not receive marketing authorization.

 

In addition, EMEA promised to take on responsibility for translating package information into different European languages.

The formation of the SME office followed complaints that the centralised system for registering drugs with EMEA was more bureaucratic and expensive than national medicines agencies.

To qualify for the discounts and use the services, companies must meet the definition of an SME, a status that will be reviewed annually.

Companies that qualify for SME status encompass a pretty broad church, ranging from micro enterprises employing less than 10 persons and with an annual turnover not exceeding €2 million to small enterprises have fewer than 50 employees and an annual turnover or balance sheet total of not more than € 10 million and medium enterprises with fewer than 250 employees and an annual turnover of not more than € 50 million.The list of those enjoying the status currently includes several publicly listed companies.

EMEA said the level of interest in the scheme has exceeded expectations. To date, 136 companies have submitted SME applications of which 108 were approved, 25 are under review, two have been withdrawn and one has expired. The large majority of these companies are developing medicinal products for human use, three are veterinary companies, and three are regulatory consultants.

Micro-enterprises represent 24 per cent of the total and this includes many start-up companies originating from university research projects.

Companies from 17 countries across Europe have applied for SME status, with the majority based in the UK, France, Germany, Denmark, Sweden and Belgium, where the majority of Europe’s biotech sector is concentrated.

In the course of its first full year the SME Office has given regulatory assistance to 14 companies on a wide variety of topics, including general regulatory strategy for obtaining a marketing authorisation, eligibility to EMEA procedures as a medicinal product, applications for orphan designation, and detailed queries from companies in the run up to the filing of an application for marketing authorisation.

Twenty-three SME companies have requested scientific advice. To date, a total of €1.4 million in SME fee reductions has been processed for scientific advice.

Eight SME companies have submitted marketing authorisation applications, seven for human drugs and one for a veterinary product. Of the human medicinal six out of seven are designated orphan medicinal products.

As yet, the translation service is still in development. It is envisaged that the English version of the product literature will be translated by the Centre for Translation in Luxembourg just prior to EMEA giving its opinion on a marketing application. The translations would then be checked by the national authorities in the member states in the usual manner.

The legislation also required EMEA to publish a detailed user guide’ for SMEs on the administrative and procedural aspects of medicines legislation that are of particular relevance to smaller companies. The first draft has been completed and is currently with the European Commission for agreement. The draft will be published on the EMEA website for a 3-month consultation period.

The first EMEA-sponsored SME Workshop, titled Navigating the Regulatory Maze, will be held on 2 February 2007.