Regulatory News

SMEs get help from EMEA

Wide range of assistance available from agency

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.

EMEA will offer help in a number of key areas including procedure and applications for marketing authorization as well as a number of financial incentives. These include fee reductions for scientific advice, pre- and post-authorization inspections, scientific services, establishment of maximum residue limits (veterinary medicines) and a full fee waiver for administrative services (with the exception of parallel distribution). Where scientific advice is followed and a marketing application is unsuccessful, a conditional fee exemption will apply.

The Standing Committees for Medicinal Products adopted the new Commission Regulation to allow provisions for SMEs outlined in the EU pharmaceutical legislation (Article 70(2) of Regulation (EC) No 726/2004). SMEs are defined in the Commission Recommendation 2003/361/EC.

www.emea.eu.int

Pandemic influenza vaccine application

The European Medicines Agency (EMEA) has received the first application for a pandemic influenza vaccine. The application, from GlaxoSmithKline Biologicals utilizes the 'core dossier' approach, which allows a more rapid response in the event of an outbreak.

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This approach facilitates the submission of an application using a mock-up vaccine for evaluation and approval. When the strain responsible for the outbreak is identified, the dossier is resubmitted to incorporate the new strain. The core dossier approach is uniquely European and should allow swift reaction to an influenza outbreak. Preparation for an influenza outbreak began in 2003 and the draft pandemic influenza crisis was issued last year.

www.emea.eu.int

For flu vaccines Speke to Medimmune

FDA has given the go-ahead for a new influenza vaccine production facility in Speke (UK). The MedImmune facility will be able to produce 15 million bulk doses per month, which equates to approximately 90 million doses per influenza manufacturing season. The plant could also help produce vaccine year round in the event of an influenza pandemic.

The site is 10 times larger than the existing Speke location and will be used to produce FluMist, an intranasal influenza vaccine. Medimmune's investigational influenza vaccine CAIV-T (cold adapted influenza vaccine, trivalent) is also planned to go into production there.

www.medimmune.com